Biosimilars in Switzerland

What separates a biosimilar from a generic

A generic is the chemically identical copy of a small molecule and can be proven analytically with precision. A biosimilar is a protein produced in living cells: it is highly similar to the reference product but not identical, because folding and glycosylation depend on the manufacturing process.

The entire regulatory difference follows from that molecular size. For a generic, demonstrating bioequivalence normally suffices. For a biosimilar, Swissmedic requires a comparative dossier that starts analytically and ends with a comparative clinical study in the most sensitive indication.

The Swissmedic authorisation route

Swissmedic assesses biosimilars under Art. 12 of the Therapeutic Products Act, in the procedure for medicines with a known active substance but with dedicated guidance. The dossier must establish comparability in stages: analytical, functional, preclinical and clinical. The authorisation expressly relies on the reference product's data.

1. Analytical comparability: primary and higher order structure, glycosylation pattern, impurity profile, stability.
2. Functional comparability: binding and cell based assays against the relevant targets.
3. Preclinical work: only where the analytical stage leaves questions open, and at reduced scope.
4. Pharmacokinetics and pharmacodynamics: a comparative study in healthy subjects or patients.
5. A comparative clinical study in the most sensitive indication, including immunogenicity data.
6. Extrapolation to the reference product's other indications where scientifically justified.

If the biosimilar deviates at any stage, Swissmedic asks for more data rather than an argument. The analytical quality of the manufacturing process therefore drives the duration and the cost of the whole procedure, not the clinical study at the end.

The price rule: at least 20 per cent below the reference

Under Art. 65cbis of the Health Insurance Ordinance a biosimilar's ex-factory price must be at least 20 per cent below the reference product's ex-factory price at admission. The FOPH additionally runs the foreign price comparison against the nine reference countries and, where comparators exist, the therapeutic cross comparison.

When the first biosimilar is admitted, the reference product loses its on-patent price: the FOPH reviews it under Art. 65e and normally cuts it too. The price gap is preserved while the level of both products falls.

• The 20 per cent gap applies to the ex-factory price, not the public price.
• Further biosimilars in the same group enter the existing price corridor.
• Price models with rebates to the insurers are possible; the published price then sits above the effective one.

Pharmacy substitution and traceability

Pharmacies may substitute a biosimilar for the reference product under defined conditions, provided the prescriber has not excluded substitution. The pharmacy informs the patient, documents trade name and batch, and receives a substitution fee for the counselling.

The documentation duty is not a formality. Biological medicines must remain traceable to the batch under Art. 59 of the Therapeutic Products Act and the pharmacovigilance reporting duties, so that an adverse reaction can be attributed to the right product. A report naming only the active substance is worthless.

• Trade name and batch number in every record and every report.
• A switch during ongoing therapy only after clinical assessment, and documented.
• Avoid repeated switching without cause, because it makes attributing adverse reactions harder.

Why Swiss biosimilar uptake lags

The biosimilar share of consumption in Switzerland sits below the European average. Three causes compound: a weak financial incentive for prescribers and patients, entrenched prescribing habits, and the separation between the hospital market and the outpatient market.

• Incentive: the raised 40 per cent co-payment bites mainly in outpatient care, and only where the price gap reaches the threshold.
• Habit: a biological therapy that has run stably for years is not switched without a reason.
• Hospital: SL prices do not bind hospital procurement; tenders and rebates decide there, and neither is visible in the outpatient price.

For manufacturers this means the price gap alone opens no share. What decides it is early engagement with the prescribing medical societies, solid switching evidence and a distribution model that addresses hospital and pharmacy separately.

What a manufacturer must plan for market entry

Bringing a biosimilar to the Swiss market is a two to three year project in which authorisation, price and channel run in parallel. The most common mistake is filing the admission request before the pricing strategy in the reference countries has settled.

1. Clarify the reference product, the patent position and supplementary protection certificates in Switzerland.
2. Set the pricing strategy and launch sequence across the nine reference countries so the foreign price comparison does not work against you.
3. File with Swissmedic and prepare the comparability data against questions.
4. File the SL request within 60 days of authorisation, with the price gap of at least 20 per cent.
5. Align the publication date on the first of a month with supply readiness and the wholesaler.
6. Have pharmacovigilance and batch traceability operational before launch.