Biosimilars in the pharmacy: the right of substitution, practice and pharmacovigilance

Since 1 January 2024, Swiss pharmacists have been authorised to replace medically prescribed original biological preparations with biosimilars containing the same active substance — analogous to the generic substitution established for years. With this, Switzerland takes a pioneering role in Europe: in most EU countries biosimilars may not be exchanged by the pharmacy professional but only through the medical prescription. [1,2] Behind the sober legal adjustment of article 52a of the health insurance act and article 38a of the health care benefits ordinance lies a health-economic signal: the Federal Council intends the measures to save around 300 million francs a year; the saving realised by generics and biosimilars in 2024 amounted, according to Intergenerika, to 707.1 million francs. [3,4] For the pharmacy this creates new competences — and new responsibilities: regulatory duties of care towards the prescribing doctor, a specific pharmacovigilance for biologicals (documentation of lot numbers), practical support for patients on injection technique, storage and the cold chain. This article sets out the most important regulatory, clinical and pharmaceutical-practical aspects for the Swiss pharmacy in 2026.

Clinical and regulatory background: biologicals, biosimilars and Swiss supply policy 2024–2026

Biologicals have been part of modern pharmacotherapy since the 1980s — beginning with recombinant human insulin. Today they encompass monoclonal antibodies, fusion proteins, growth factors, hormones, enzymes and antithrombotic polysaccharides. They revolutionised the treatment of chronic inflammatory and oncological diseases: adalimumab, etanercept and infliximab in rheumatology, dermatology and gastroenterology; rituximab, trastuzumab and bevacizumab in oncology; filgrastim and pegfilgrastim for neutropenia prophylaxis in chemotherapy; epoetin alfa in renal anaemia; insulin glargine in diabetes care. [9]

With the patent expiries of the major original preparations from the late 2000s, the market opened up for biosimilars. The world’s first biosimilar was somatropin (Omnitrope®, Sandoz), authorised by the EMA on 12 April 2006. In Switzerland, Binocrit® (epoetin alfa, Sandoz) was the first authorised biosimilar in December 2009, followed by Zarzio® (filgrastim) and Omnitrope® (Swissmedic authorisation in July 2010). Today 45 biosimilars are authorised in Switzerland, a doubling compared with 2019. [3,9]

Economically the potential is substantial: the biosimilar-eligible market in Switzerland amounts to around 0.565 billion francs (out of a total medicines market of about 9 billion francs). The substitution rate of 36.4% in 2024 is markedly higher than in previous years (<10%), but still clearly below the generics figure of 69%. [3,4] The Federal Council intends the measures introduced to save 300 million francs a year. For compulsory health insurance this leverage is relevant: biologicals are among the most expensive therapies in the Specialities List assortment — adalimumab, for example, with annual treatment costs of several thousand francs.

Switzerland took a decisive step in 2023: the Federal Office of Public Health and Swissmedic confirmed in a joint statement the interchangeability and substitutability of biosimilars with their original preparations. [5] This statement dissolved the last remaining reservation about pharmacy substitution. As of 1.1.2024, article 52a of the health insurance act was adjusted accordingly, and article 38a of the health care benefits ordinance doubled the differentiated co-payment for more expensive original preparations to 40% — now also for biotechnologically manufactured medicines. [1] The pharmacy thereby becomes a central lever of the measures to promote biosimilars.

What is a biosimilar? Scientific distinction from generics

A biosimilar is a biological medicine that shows sufficient similarity to a biological reference preparation already authorised by Swissmedic and refers to its documentation. The legal basis in Switzerland is article 4 para. 1 let. anovies of the Therapeutic Products Act. [7]

What distinguishes biosimilars from generics is the complexity of the active molecules. Conventional medicines («small molecules», for example acetylsalicylic acid, ibuprofen, atorvastatin) typically consist of chemically synthesised molecules with a mass below 1 kilodalton (kDa) and an unambiguously defined chemical structure. Generics of these substances can be reproduced in chemical identity. [12]

Biologicals, by contrast, are large, complex proteins produced with the help of living cells or organisms (bacteria, yeasts, mammalian cells such as Chinese hamster ovary cells). Their molecular mass is 5 to 150 kDa and they can consist of hundreds of amino acids, often with glycosylations, disulfide bridges and complex three-dimensional folding. Exact chemical identity between different manufacturing batches — even of the original preparation — is technically impossible. Biosimilars are therefore not identical to the reference preparation but — as the name says — similar: with clinically irrelevant deviations in the microstructure, but identical effectiveness and comparable safety. [7,12]

The precondition for authorisation as a biosimilar is a comprehensive comparability exercise. This encompasses: (a) physicochemical analysis of the molecule (amino acid sequence, folding, glycosylation pattern, post-translational modifications, aggregates, impurities); (b) biological activity in vitro and in vivo; (c) clinical pharmacokinetics and pharmacodynamics; (d) efficacy and safety studies (to the extent necessary to demonstrate comparability — with strict biological comparability, pharmacokinetic and pharmacodynamic comparative studies are often sufficient). The data are examined by Swissmedic in the procedure under article 11 of the Therapeutic Products Act. [7,8]

Since January 2024 Swissmedic has — in line with the EMA reflection paper on a tailored clinical approach in biosimilar development — accepted applications even without data from comparative efficacy studies. The precondition: a conclusive justification in the cover letter, and existing scientific advice from the EMA and/or the US FDA. The bridging study to a Swiss comparator preparation formerly required has likewise been dropped since 2024, where the suitability of the EU/US comparator can be demonstrated in accordance with chapter 5.4.1 of the biosimilar guidance. [8]

The Swissmedic authorisation path: guidance, comparability, extrapolation

The Swiss authorisation path for biosimilars is set out in the guidance «Authorisation of biosimilars» (document number ZL101_00_012d) and in the FAQ document on the authorisation of biosimilars (revised January 2024). [7,8] Both documents are regularly updated; the current status is available on the Swissmedic website under «Human medicines → Authorisations → Information».

Important Swiss specifics of biosimilar authorisation: [7,8]

• Comparator preparation: the comparator in the comparability studies may be the Swiss reference preparation or the preparation authorised and marketed by the EMA or the US FDA. Supplementary studies may be conducted with comparators from other countries with comparable medicines control.
• Bridging requirement dropped (since January 2024): where the EU/US comparator was used in the comparative studies, no additional bridging study to the Swiss reference preparation has been required since 2024. The precondition: the suitability of the comparator is demonstrated in accordance with chapter 5.4.1 of the biosimilar guidance.
• Comparative efficacy studies no longer mandatory: these are no longer required in every case. Swissmedic accepts applications based on comprehensive analytical and pharmacokinetic/pharmacodynamic comparability.
• Risk management plan: biosimilar applications are not subject to a mandatory risk management plan. Where educational materials or other risk-minimising measures are provided for the safe use of the reference preparation, Swissmedic examines in the biosimilar application whether these are also necessary for the biosimilar.
• Medicine information: the medicine information of the biosimilar need not be an exact copy of that of the Swiss reference preparation, but all applicable passages must be identical. Since a biosimilar need not have all the indications of the reference preparation (so-called extrapolation), the professional information may differ in the section «Indications / possible uses».
• Extrapolation of indications: a biosimilar need not have all the indications of the reference preparation. The extrapolation of an indication can be applied for where the mechanism of action, pharmacokinetics, pharmacodynamics and immunogenicity can be assessed as similar.

A practical consequence for pharmacy practice: it can happen that the authorised indications of the reference preparation and of individual biosimilars are not fully congruent. Before substituting, a look at the professional information of the specific biosimilar to be dispensed is important, particularly with less common or off-label uses. [7,8]

Article 52a of the health insurance act and article 38a of the benefits ordinance: the right of substitution and the differentiated co-payment since 1.1.2024

By decision of 22 September 2023 the Federal Council adopted two central adjustments, which entered into force on 1 January 2024 and form the regulatory foundation of biosimilar substitution by pharmacists. [1,5]

Article 52a of the health insurance act (revised version since 1.1.2024): pharmacists may substitute more expensive medicines with cheaper medicines containing the same active substance. The original wording was limited to generic substitution; the revision expressly extends this competence to biosimilars. [1] The detailed provisions are set out in the health insurance ordinance.

Article 38a of the health care benefits ordinance (revised version since 1.1.2024): the differentiated co-payment for original preparations that are too expensive compared with medicines containing the same active substance was raised from 20% to 40%. This rule now also applies to biotechnologically manufactured medicines. For medicines whose ex-factory price exceeds the average of the cheapest third of the preparations containing the same active substance, the increased co-payment applies. [1,6]

A practical consequence for patients: anyone who obtains an original biological even though a biosimilar would be available pays 40% instead of 10% co-payment — a financial incentive that makes biosimilars attractive for patients. The insured must be informed about the higher share of costs. [6]

Pharmacists’ duties when substituting [1,5,15]:

• Information to the prescribing doctor: the pharmacy professional must inform the prescribing doctor in writing of every substitution. This may be done electronically (through the electronic patient record, a practice software interface, a fax or a secure email solution) or by letter. Without this information, substitution may not take place. [15]
• Information to the patient: the substitution must be explained. The patient’s agreement is a precondition; the patient may refuse a substitution (in which case they bear the increased co-payment of 40%, where no medical exception is documented).
• Medical exceptions from substitution (art. 38a of the benefits ordinance): refusal on medical grounds must be evidenced and documented. Evidence includes, for example, that treatment attempts with at least one cheaper medicine containing the same active substance led to intolerance or an insufficient therapeutic response. In these cases the increased cost share for the insured does not apply.
• Supply shortages: where the unavailability of the cheaper preparation is documented, the more expensive one may be dispensed with the note «substitution not possible», likewise without an increased co-payment. Evidence, for example, by means of a screenshot of the ordering window at the wholesaler. [6]
• No renewed cost approval: for biosimilars it has additionally been defined that no renewed cost approval by the health insurer is required when switching from the reference preparation to a biosimilar, where such approval already exists for the reference preparation. [3]
• LOA reimbursement — an important clarification: until the end of 2025 (LOA IV/1) the Swiss pharmacy tariff reimbursed the substitution service only for generics, not for biosimilars. With the new tariff agreement LOA V (approved by the Federal Council on 29.10.2025, in force from 1.1.2026), the substitution service is newly remunerated for biosimilars as well — pharmaSuisse president Martine Ruggli describes this as recognition of the central role of pharmacies in primary care. Contracting parties: pharmaSuisse, prio.swiss, HSK, CSS. The tariff was introduced cost-neutrally; for the first time it also integrates mail order and machine blister packing. [16]

The Swiss naming convention: invented name and INN

The Swiss naming convention for biosimilars differs from US practice and is relevant to pharmacy practice — both for correct recording in the patient file and for pharmacovigilance reporting. [7]

Generics carry the internationally used short name of the active substance (the international nonproprietary name, INN) combined with a company designation — for example «Adalimumab-Mepha». The INN comes before the trade or company name.

Biosimilars carry either an INN–manufacturer name or an invented name. Where an invented name is chosen — as is the case with most Swiss biosimilars (e.g. Hyrimoz®, Imraldi®, Hulio® for adalimumab) — the active substance name (INN) must be shown beneath the trade name. The legal basis: article 12 para. 1 in conjunction with annex 1 no. 1 para. 4 of the ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the requirements for the authorisation of medicines (AMZV; SR 812.212.22). [7]

No US suffixes in Switzerland: since 2017 the US FDA has given biosimilars a four-letter suffix to the INN (e.g. «adalimumab-bwwd» for Hadlima®, «adalimumab-adaz» for the US variant of Hyrimoz®). This convention is not applied in Switzerland. Swiss biosimilars simply carry the INN beneath the trade name. [7]

A consequence for pharmacy practice: in patient documentation, on the prescription, in the delivery and in the pharmacovigilance report, the trade name (invented name) is always to be used in addition to the INN. Stating the INN alone is not sufficient for biologicals — in contrast to synthetic medicines. A report of «adalimumab» without specifying the concrete preparation does not allow the specific batch to be traced. [13,14]

Switching evidence: NOR-SWITCH and further studies

The most important and most frequently cited switching study is the randomised, double-blind NOR-SWITCH study funded by the Norwegian government (Jørgensen et al., Lancet 2017; n=482 adults from 40 Norwegian centres). [10] Included were patients with disease stable for at least 6 months on the infliximab original preparation (Remicade®) in six indications: Crohn’s disease (n=155), ulcerative colitis (n=93), rheumatoid arthritis (n=77), ankylosing spondylitis (n=91), psoriatic arthritis (n=30), plaque psoriasis (n=35). 241 patients continued to receive the original preparation, 240 were switched to the biosimilar CT-P13 (Remsima®/Inflectra®).

The primary endpoint was an indication-specific worsening of disease over 52 weeks, with a predefined non-inferiority margin of 15%. The result: switching was not inferior to continuing the original preparation. Safety and immunogenicity were comparable between the groups. [10]

The NOR-SWITCH extension (Goll et al., J Intern Med 2019; n=380 of 438) extended the observation to 78 weeks and showed no difference in safety, efficacy and immunogenicity between patients who received CT-P13 throughout and patients who were switched at week 52. [11]

Beyond NOR-SWITCH, numerous further switching studies and systematic reviews are now available. A widely cited systematic literature review by Cohen et al. (Drugs 2018; 78(4): 463–478) identified 90 switching studies with a total of 14,225 patients, seven molecular entities and 14 indications. Across all studies, neither clinically relevant losses of effectiveness nor an increased safety or immunogenicity risk were found. A limitation: the lead author Hillel P. Cohen is an employee of Sandoz (the first distributor of numerous biosimilars). A methodological critique (Pires et al., Drugs 2018) notes that this is a «systematic literature review» and not a Cochrane systematic review with formal risk-of-bias assessment. The conclusion — no consistent signal of increased risks from switching — was successfully defended by the authors. [12] On this and further data, the Federal Office of Public Health and Swissmedic published their 2023 statement on the interchangeability of biosimilars and original preparations — the regulatory basis for pharmacy substitution as of 1.1.2024. [5]

Nocebo effects are known from clinical practice: where a switch from the original preparation to a biosimilar is not sufficiently accompanied and communicated, patients report subjectively more often a loss of effect or new complaints — which cannot be explained by pharmacological differences. This phenomenon is clinically relevant for pharmacy communication: a factual, engaged explanation of the safety and efficacy evidence, without appearing defensive, is part of professional substitution. [12,15]

The Swiss biosimilar market 2024: 45 preparations, 15 substance classes

As at 2024, 45 biosimilars covering 15 active substance classes are authorised in Switzerland — a doubling compared with 2019 (then 22 biosimilars). [9] Below are the most important substance classes with the reference preparation and the biosimilars available in Switzerland (IQVIA Pharmamarkt Schweiz 2024):

• Adalimumab (reference: Humira®): Abrilada®, Amgevita®, Hukyndra®, Hulio®, Hyrimoz®, Idacio®, Imraldi®, Yuflyma® — the most broadly occupied biosimilar field in Switzerland. Adalimumab biosimilar market share in 2024: 38% — the lowest value of all substances covered by biosimilars in Switzerland, 51 months after the market entry of the first biosimilar. [3,9]
• Bevacizumab (reference: Avastin®): Bevacizumab Teva®, Mvasi®, Oyavas®, Vegzelma®, Zirabev®. The highest Swiss biosimilar market share in 2024: 69%. [9]
• Enoxaparin sodium (reference: Clexane®, Clexane Multi®): Hepaxane®, Inhixa®, Inhixa Multi®. A low molecular weight heparin — one of the few biosimilars that is a polysaccharide (not a protein).
• Epoetin alfa (reference: Eprex®): Binocrit®. A growth factor for erythropoiesis, used in chronic renal insufficiency and chemotherapy-induced anaemia.
• Etanercept (reference: Enbrel®): Benepali®, Erelzi®. Market share 2024: 49%. [9]
• Filgrastim (reference: Neupogen®): Accofil®, Filgrastim Teva®, Zarzio®, Zarzio P5H®. G-CSF for treating chemotherapy-induced neutropenia.
• Follitropin alfa (reference: Gonal F®): Ovaleap®. An FSH analogue in reproductive medicine.
• Infliximab (reference: Remicade®, Remicade APS®): Inflectra®, Remsima®, Remsima APS®. CT-P13 (Remsima/Inflectra) was the substance in the NOR-SWITCH study. [10,11]
• Insulin glargine (reference: Lantus®): Abasaglar®. A long-acting insulin in diabetes care.
• Pegfilgrastim (reference: Neulasta®): Fulphila®, Grasustek®, Pelgraz®, Ziextenzo®.
• Ranibizumab (reference: Lucentis®): Byooviz®, Ranivisio®, Ximluci®. Anti-VEGF therapy in ophthalmology (age-related macular degeneration, diabetic macular oedema).
• Rituximab (reference: Mabthera®): Rixathon®, Truxima®. Market share 2024: 51%. [9]
• Somatropin (reference: Genotropin®): Omnitrope® — the world’s first biosimilar of all, EMA authorisation on 12.4.2006, authorised in Switzerland by Swissmedic in July 2010 (after Binocrit® and Zarzio®, the third biosimilar on the Swiss market).
• Teriparatide (reference: Forsteo®, Eli Lilly Suisse SA, Compendium 127478): the Swiss biosimilars Livogiva®, Movymia®, Sondelbay® (Compendium 1508558), Terrosa® (Compendium 1404380). Additionally available: Teriparatid-Mepha® (fully synthetic and therefore, strictly speaking, a hybrid; Compendium 1373460). A PTH analogue for the treatment of severe osteoporosis, second-line after bisphosphonate/SERM/calcitonin/denosumab according to the Specialities List limitatio. Treatment duration a maximum of 24 months.
• Trastuzumab (reference: Herceptin®): Herzuma®, Kanjinti®, Ogivri®, Trazimera®. HER2-targeted antibodies in breast cancer therapy. Market share 2024: 48%. [9]

Economic effects in 2024 (Federal Office of Public Health / IQVIA January 2025): with chemical active substances the turnover of the original preparations fell by CHF 86.1 million and that of the generics grew by CHF 118 million. With biological active substances the turnover of the original preparations fell by CHF 105.7 million and that of the biosimilars grew by CHF 50.1 million. The saving for premium payers in 2024 (generics and biosimilars together): CHF 707.1 million (Intergenerika 2025). [3,4]

Pharmacovigilance with biologicals: lot number, immunogenicity, reporting

Pharmacovigilance is particularly important with biologicals — and for biosimilars in Switzerland it is also regulated in particular detail. The central point: unlike synthetic medicines, biologicals from different batches can show slight microheterogeneity. A rare adverse effect traceable to a specific batch or a specific manufacturer can only be followed up if the batch (lot number) has been reliably documented. [7,13,14]

The Swiss requirement for the pharmacy: when dispensing biological medicines — including biosimilars — the lot number (batch number) should be recorded in the patient documentation. In the event of a suspected adverse drug reaction this enables exact assignment to the batch dispensed. Practical implementation in the Swiss pharmacy: the lot number is recorded automatically when scanning the data matrix code of many biologicals (where the pharmacy software supports this) or entered manually into the file.

Suspected adverse drug reaction — duty to report: in Switzerland pharmacists are obliged to report serious or new adverse drug reactions to Swissmedic — through the online portal ElViS (Electronic Vigilance System) at www.swissmedic.ch. With biologicals the following details must be included: (a) trade name and INN, (b) lot number, (c) indication, (d) duration of use, (e) detailed symptoms, (f) time course, (g) concomitant medication. [13]

Immunogenicity as a biological-specific issue: biologicals can trigger, in some patients, the formation of anti-drug antibodies, which can lead to a loss of effect («secondary failure»), hypersensitivity reactions or infusion reactions. Immunogenicity depends on the substance, the manufacture and the patient. Where there is a loss of effect under a biological (original or biosimilar), an anti-drug antibody test should — after medical assessment — be considered. An observation from the pharmacy side: where patients report a loss of effect after substitution, the nocebo effect is a differential diagnosis — but genuine secondary immunogenicity is also possible and belongs in a medical work-up. [10,12,15]

Patient education: patients should be encouraged to report every suspected adverse effect — including with the original biological. The pharmacy can take on an important bridging function here: a low-threshold initial recording of the account, capture of the lot number from the preparation the patient has with them, and a joint online report through the ElViS portal.

Pharmacy practice: the substitution conversation, pens, the cold chain, disposal

Practical pharmacy support of patients on biologicals and biosimilars encompasses far more than regulatory substitution. Four topics are particularly relevant in the Swiss pharmacy:

1. The substitution conversation. Substitution must not take place tacitly — it is communicated. A proven conversational structure: (a) a factual, positive opening («I can dispense you a biosimilar to your usual adalimumab original preparation today — it is therapeutically equivalent and cheaper for you.»); (b) a brief explanation of the concept («Biosimilars are made with the same active substance and have been demonstrated in numerous studies to be equivalent to the original preparation — in safety as well.»); (c) addressing the differentiated co-payment («If you prefer the original, your co-payment would not be 10% but 40% of the costs.»); (d) mentioning the written information to the prescribing doctor; (e) offering patient self-determination («Would you like the biosimilar or shall we stay with the original?»).

2. Pen and injection technique. Most biologicals are administered as a subcutaneous injection using a prefilled syringe or a prefilled pen. Different biosimilars of one active substance can have different pen designs — a real practical difference that requires patient training on substitution. With adalimumab, for example, these differ: (a) operating steps: Hyrimoz® SensoReady, Hulio®, Imraldi®, Yuflyma® and Hukyndra® use a 2-step technique (remove cap → press against skin), while Humira® and Amgevita® SureClick use a 3-step technique (remove cap → press against skin → press the trigger). (b) Concentration and volume: there are low-concentration (LCF, 50 mg/mL, citrate-containing) and high-concentration (HCF, 100 mg/mL, citrate-free) formulations. Citrate as a buffer component is associated with injection pain or burning; HCF formulations reduce the injection volume and the perception of pain. (c) The Swiss Compendium reality for adalimumab 40 mg (as at May 2026): Humira® is available as a 40 mg/0.4 ml prefilled pen (HCF, citrate-free), Hyrimoz® SensoReady as a 40 mg/0.8 ml prefilled pen (LCF, citrate-containing). With a substitution from Humira® to Hyrimoz® SensoReady, the injection volume (doubled) and the buffer system (citrate newly present) therefore change. A practical pharmacy recommendation: give the patient the manufacturer’s written instructions for use, demonstrate on a trainer pen, point to the manufacturer’s hotline and patient support programmes; where burning on injection is reported with the LCF formulation, longer acclimatisation to room temperature (30+ minutes before injection) can reduce the difference.

3. Cold chain and storage. Biologicals are as a rule temperature-sensitive. Storage in the refrigerator at 2–8 °C, protected from light, never frozen. Practical pharmacy advice: a continuous cold chain in delivery and dispensing; a cool bag for the patient’s journey home; clear explanation of storage at home (the upper or middle part of the refrigerator, not the door compartment because of temperature fluctuations); take out of the refrigerator 30 minutes before injection to reach room temperature (this reduces pain and local reactions); observe the maximum storage time outside refrigeration (variable by product, typically 14–30 days at room temperature — consult the professional information).

4. Disposal. Used prefilled pens and syringes belong in a sharps container. Pharmacies can take an important role here: give the patient a sharps container, dispose of empty containers in the pharmacy, and point out the prohibition on disposal in household waste.

Adherence monitoring is central in chronic therapy with biologicals. The pharmacy sees the regular re-dispensing and can intervene promptly where the collection pattern deviates — for example through a low-threshold query («I saw that you hadn’t been to us for a while; is there anything you’d like to come back to?»). Where non-adherence is documented, inform the treating practice. [15]

Four typical counselling situations

Four typical counselling situations around biosimilars in the Swiss pharmacy — with concrete substitution and communication decisions:

1. A rheumatology patient on original adalimumab with reservations about substitution

Ms H., 52, comes with her prescription for Humira® (adalimumab original) 40 mg/0.8 ml for her rheumatoid arthritis. She has been stable on the original preparation for five years. She says: «I’ve heard that I’m now supposed to get a different adalimumab. Is it really exactly the same?» — Open question: «What have you heard about biosimilars, and what concerns you most?» Reflective listening: «You want certainty that your well-functioning therapy will not be thrown off — that is a legitimate concern.» Professional classification: biosimilars are authorised on the basis of comprehensive comparability with the original; the Federal Office of Public Health and Swissmedic confirmed interchangeability in 2023; the NOR-SWITCH study showed no inferiority in around 480 patients over two years — in safety as well. [5,10,11] The active substance is identical in amino acid sequence and function; only the microstructure (glycosylation pattern) can deviate minimally, which is not clinically relevant. Practical implementation: «I can dispense you Hyrimoz® today — active substance adalimumab, the same dose of 40 mg/0.8 ml, the same injection schedule, a slightly different pen. The additional cost with the original would be a co-payment of 40% instead of 10% for you. I will inform your rheumatologist of the substitution by fax.» If refused: respect the patient’s wish, dispense the original, explain and document the increased co-payment clearly. Not to be underestimated: if the patient is nervous, it is better to dispense the original and hold the conversation about substitution at a calmer moment — nocebo effects are reinforced by uncertainty. [15]

2. A patient with diabetes on insulin glargine and a question of understanding

Mr M., 64, with type 2 diabetes, has a prescription for a Lantus® 100 U/ml pen (insulin glargine). He asks: «My diabetologist hinted that I might switch to a different one later. Can that just be done, without my sugar getting thrown off?» — Open question: «How are you measuring your values at the moment, and how well controlled are you?» Professional classification: Abasaglar® is the insulin glargine biosimilar authorised in Switzerland. The comparability studies (ELEMENT-1 and ELEMENT-2) showed the same effectiveness and safety as the original Lantus®. [9] Practical implementation: «With a switch from Lantus® to Abasaglar® the insulin dose as a rule stays the same — but in the first weeks your diabetologist, or you, will check the values more closely to make sure your control remains stable. Operating the Abasaglar® pen differs slightly from the Lantus® pen — I’m happy to show you the difference if the substitution becomes relevant today.» The pharmacy’s role: training on the pen change, sensitivity to hypo- and hyperglycaemia in the first weeks, documenting the lot number, low-threshold contact with diabetes counselling.

3. An oncology patient with a question about trastuzumab in adjuvant therapy

Ms S., 48, HER2-positive breast cancer, in adjuvant therapy. She comes with a prescription for Herceptin® (trastuzumab) intravenously, with the 6th cycle upcoming. Her oncologist’s hospital report says «Herceptin or biosimilar according to availability». She is worried: «My cancer is aggressive — should I take the cheapest one?» — Open question: «What does this therapy mean to you exactly — how important is it?» Reflective listening: «You are very concerned about your cure — that is exactly the right concern, which we must take seriously together.» Professional classification: in oncology the safety of substitution is particularly well documented: trastuzumab biosimilars (Herzuma®, Kanjinti®, Ogivri®, Trazimera®) have been compared with the original in numerous studies — effectiveness (e.g. pathological complete response rates in neoadjuvant therapy), safety and immunogenicity were comparable. [9,12] Practical implementation: «Your oncologist has herself permitted substitution in the prescription — that means she has decided clinically that the original and the biosimilar are therapeutically equivalent in your case. Trastuzumab biosimilars have been used worldwide for many years, including in adjuvant therapies such as yours. Effectiveness and safety are demonstrably comparable. You can rely on the therapy.» Where deeper reassurance is needed: recommend addressing the oncologist directly before the next appointment — for personal support of the treatment decision the treating physician is the right person.

4. A self-paying patient who wants the cheaper biosimilar

Mr K., 45, self-paying and resident in Switzerland (a co-payment option with a high deductible), has a prescription for etanercept (Enbrel®) for his psoriatic arthritis. He asks: «Isn’t there a cheaper product? I’m paying for it myself in the first half of the year.» — Open question: «Do you already know what Enbrel® costs you per month?» Professional classification: etanercept biosimilars in Switzerland: Benepali®, Erelzi®. The etanercept biosimilar market share in 2024: 49%. [3,9] Practical implementation: «Yes, I can dispense you Benepali® — active substance etanercept, the same dose of 50 mg/ml, the same regimen (as a rule once weekly subcutaneously). The list price is lower than for Enbrel®. I will inform your prescribing practice in writing. Shall I work out the exact price difference for you before you decide?» Important: with self-payers the lever of the differentiated co-payment does not apply, but the direct cost advantage remains. The procedure is regulatorily identical: written information to the doctor, documenting the lot number, patient education.

Practice tool: Swiss biosimilars 2024 at a glance

The most important substance classes with the Swiss reference preparation and a selection of the available biosimilars. Status: IQVIA Pharmamarkt Schweiz 2024 (45 biosimilars, 15 active substances). The current Specialities List with all substitution markings is available at spezialitaetenliste.ch.

Swiss tariff: LOA reimbursement, margins, co-payment

The economic classification of biosimilar substitution in Swiss pharmacy practice is regulated at several levels.

LOA reimbursement in transition — the pharmacy tariff LOA V since 1.1.2026: performance-based remuneration as a tariff for the pharmaceutical service was decisively extended by the new LOA V (Federal Council approval 29.10.2025, in force 1.1.2026). Until the end of 2025 (LOA IV/1) the health insurers reimbursed the pharmacy’s substitution service only for classic generics (synthetically manufactured), not for biosimilars. There was thus a two-year gap between the entry into force of the extended right of substitution under art. 52a of the health insurance act (1.1.2024) and the entry into force of LOA V (1.1.2026): pharmacists were allowed to substitute biosimilars, but had no separate tariff entitlement for this counselling service. With LOA V — negotiated between pharmaSuisse, prio.swiss (the association of Swiss health insurers), HSK and CSS, and submitted in summer 2024 — the substitution service is now regularly remunerated for biosimilars too, analogously to generic substitution. The tariff is cost-neutral; for the first time it also integrates pharmaceutical services in the mail order channel and machine blister packing. [16]

Statement from pharmaSuisse: «With the approval of LOA V the Federal Council recognises the central role of pharmacies in primary care. The new tariff structure improves patient safety, strengthens care in nursing homes and creates transparency in the system» — Martine Ruggli, president of the Swiss Pharmacists’ Association pharmaSuisse (press release of 29.10.2025). [16]

A practical consequence for pharmacy practice from 1.1.2026: dispensing and the counselling associated with substitution (including the written information to the prescribing doctor) is regularly remunerated. The substitution service is thus economically equivalent to dispensing the original preparation — the pharmacy has no financial incentive to favour one preparation or the other. The substitution incentive works through the patients’ differentiated co-payment (40% instead of 10%).

Margin on biologicals: with the health insurance act revision as of 1.1.2024 a new distribution margin regime applies, with the same distribution share for medicines containing the same active substance. This removes earlier margin incentives that had favoured the more expensive variant. [1,6]

The differentiated co-payment — concretely for patients: [6]

• A co-payment of 10% when obtaining a generic or biosimilar, or an original preparation without an alternative containing the same active substance.
• A co-payment of 40% when obtaining an original preparation whose ex-factory price is above the defined average — since 1.1.2024 also for biotechnologically manufactured medicines.
• Exceptions (10% co-payment despite obtaining the more expensive preparation): documented medical grounds (e.g. demonstrated intolerance or insufficient therapeutic response with the cheaper preparation); a supply shortage with evidence (e.g. a screenshot of the wholesaler order).

Specialities List adjustments: the Federal Office of Public Health published the Specialities List data effective 1.1.2024 as early as before Christmas 2023 — a few days earlier than usual, to give pharmacy systems time to implement them. The data can be retrieved as an Excel or XML file at spezialitaetenliste.ch. With every substitution decision, the current price level and substitution status of the specific preparation should be consulted — prices can vary even within the same biosimilar family. [6,17]

Cost approval: an important practice rule: for biosimilars it has been defined that no renewed cost approval by the health insurer is required when switching from the reference preparation to a biosimilar, where such approval already exists for the reference preparation. [3] The administrative hurdle is thus minimal — an important practical advantage over the previous situation.

Safety, interactions, pregnancy

General safety rules for biologicals and biosimilars in pharmacy practice:

Immunogenicity as the central safety topic. Biologicals can induce anti-drug antibodies — more rarely with fully human monoclonal antibodies (e.g. adalimumab, denosumab, dupilumab), more frequently with chimeric antibodies (e.g. infliximab, rituximab). These antibodies can lead to a loss of effect, allergic reactions and, in rare cases, anaphylactic reactions. Immunogenicity is not specifically a biosimilar problem; it occurs to a comparable extent with the original and the biosimilar preparation. [10,12]

Loss of effect after substitution. Differential diagnosis: (a) nocebo effect (very common, above all where the substitution is inadequately communicated); (b) genuine secondary immunogenicity (possible, belongs in a medical work-up); (c) disease progression independent of the substitution. From the pharmacy side: where a loss of effect is reported, initiate a medical assessment, document the lot number and where appropriate have an anti-drug antibody test considered. [12,15]

Allergic reactions. These can occur with any biological — original as well as biosimilar. More frequently with intravenous preparations (infliximab, rituximab, trastuzumab) than with subcutaneous ones (adalimumab, etanercept). In pharmacy counselling: explain the symptoms (skin rash, breathlessness, dizziness, clouded consciousness), explain the threshold for calling emergency services, and with every reaction secure the lot number of the specific batch.

Infection risk. All anti-TNF-α biologicals (adalimumab, etanercept, infliximab, certolizumab, golimumab) increase the risk of bacterial and mycobacterial infections (particularly tuberculosis reactivation) as well as viral infections (herpes zoster, hepatitis B reactivation). Before starting therapy: tuberculosis screening (an interferon gamma release assay or a tuberculin skin test, a chest X-ray), hepatitis B/C status, HIV status. Live vaccines are contraindicated during therapy; inactivated vaccines (influenza annually, pneumococci, Covid, herpes zoster with Shingrix) should be brought up to date before or during therapy. [9,15]

Malignant disease. With biologicals, general caution applies in patients with a history of tumours — particularly lymphomas and skin tumours. From the pharmacy side: skin self-examination is an important counselling point; an annual dermatological check is recommended.

Storage and stability. Biologicals are temperature-sensitive. Observe the in-use and stability information of the specific preparation — here too the biosimilar and the original can vary slightly. Document breaks in the cold chain immediately; depending on the duration and temperature of the break, the preparation must be disposed of (professional information, manufacturer’s hotline).

Pregnancy and breastfeeding. Regulated substance by substance. Anti-TNF-α biologicals are not generally contraindicated in pregnancy (above all certolizumab pegol, which crosses the placenta only minimally) — but the decision belongs in the hands of the treating physician. For biosimilars the same pregnancy recommendations apply as for the reference preparation.

Switching between different biosimilars of the same active substance (between biosimilar A and biosimilar B, e.g. between Hyrimoz® and Hulio® for adalimumab): this is treated pragmatically in Switzerland like a substitution and is as a rule therapeutically unproblematic, provided both preparations were authorised as biosimilar to the same reference preparation. Caution: the pen mechanics can differ — check the need for training.

Outlook: 2026 to 2030

Biosimilar substitution by pharmacists has been established in Switzerland for only a little more than two years. The first analyses show success — the substitution rate has risen from below 10% to 36.4%, and the saving in 2024 is around CHF 50 million from the biosimilar segment alone. [3,4] Four developments will shape the coming years:

First: a growing biosimilar pipeline. With the patent expiry of further major biologicals in the coming years, new biosimilars will enter Swiss care. Denosumab (reference: Prolia®/Xgeva®) is currently the most active substance class: the first biosimilars were authorised in March 2024 by the US FDA and the EMA (Sandoz Jubbonti®/Wyost®). By the end of 2025 the European Commission had granted marketing authorisations for seven further denosumab biosimilar pairs — among them Celltrion Stoboclo®/Osenvelt®, Fresenius Kabi Conexxence®/Bomyntra®, STADA Kefdensis®/Zvogra® (Alvotech AVT03 licence), Henlius/Organon Bildyos®/Bilprevda®, Teva Ponlimsi®/Degevma®, Dr Reddy’s Acvybra®/Xbonzy®. Swissmedic authorisations for denosumab biosimilars are expected to follow. Ustekinumab (reference: Stelara®) — the patent expired in the US at the beginning of 2025 and in the EU in September 2024; several biosimilars (STADA, Alvotech, Celltrion and others) are authorised in the EU/US, and in Switzerland are in the authorisation procedure or before market entry. Aflibercept (reference: Eylea®) — the EU patent expires in 2025–2026, the first biosimilars (STADA and others) are already authorised in the EU, and several Swiss applications are under evaluation. The range of substitutable substances will thus continue to grow.

Second: simplified authorisation procedures. Since January 2024 Swissmedic has accepted applications without comparative efficacy studies and without bridging studies, provided the suitability of the EU/US comparator can be demonstrated. This shortens the authorisation path and reduces development costs — both preconditions for even lower biosimilar prices. The EMA reflection paper on a tailored clinical approach in biosimilar development is becoming the standard. [8]

Third: LOA V as the decisive economic lever from 1.1.2026. With the entry into force of the tariff agreement LOA V, the pharmacy’s substitution service is for the first time remunerated for biosimilars — no longer only for generics. This closes the economic logic: from 2026 pharmacists have the same tariff basis for biosimilar substitution as for generics and can bill the counselling and information service as a regular pharmaceutical service. pharmaSuisse expects this to raise the substitution rate further. [16]

Fourth: digitalisation of substitution communication. The written information to the prescribing doctor is today often still paper- or fax-based. With the introduction of the electronic patient record and electronic prescribing systems, substitution information will be digitally integrated — with clear linkage of the lot number, an automatic pharmacovigilance pipeline and faster feedback channels. Pilot projects on biosimilar substitution integrated into the electronic patient record are running in several Swiss cantons.

Fifth: substitution between biosimilars. At present the substitution from original to biosimilar is as a rule clinically accepted. Substitution between biosimilars of the same active substance (e.g. from Hyrimoz® to Hulio® for adalimumab) will also increase in Switzerland, for instance when pharmacies adjust their assortment for procurement reasons. International data likewise show no increased safety risk for multiple switching. [12] Nevertheless: good communication, pen training and adherence support remain core tasks of community pharmacy.

The pharmacy’s role in the future. Biosimilar substitution is exemplary of the extension of pharmaceutical competence in Switzerland: away from the pure dispensing function, towards a clinical counselling and safety service. This development will accelerate in the coming years — not least with the health insurance act revision extending the pharmacy services reimbursed by compulsory health insurance from 2027 (vaccination, medication review, screening programmes). The pharmacy is becoming a central clinical building block of care.