Generics and biosimilars in Switzerland

A generic and a biosimilar are not the same thing

A generic is authorised on bioequivalence with the originator: a pharmacokinetic study is normally enough. A biosimilar needs a comparability exercise, meaning a chain of analytical, non-clinical and clinical data, because a biological molecule can never be rebuilt identically.

When a generic may enter the market

Documentation protection, regulatory authorisation and patent rights must be assessed separately. Swissmedic may assess an application for an essentially identical medicine before documentation protection expires and make the decision effective at a later date. An authorisation does not remove patent rights that may still prevent market launch.

In practice an authorisation can exist while market access is still blocked. That is why the directory sometimes shows several generics with first authorisation dates close together, as soon as protection falls away. The holders are then often Mepha Pharma AG, Sandoz Pharmaceuticals AG, Viatris Pharma GmbH or Spirig HealthCare AG; a brand such as Zentiva appears in the directory under its authorisation holder Helvepharm AG.

Substitution and the co-payment

Under Art. 52a of the Health Insurance Act a pharmacy may replace a more expensive originator with a cheaper generic, unless the prescriber explicitly requires the originator. Choosing the expensive originator when a generic exists triggers a higher patient co-payment, set by the Federal Office of Public Health.

• The pharmacy informs the patient about the substitution.
• The prescriber can exclude substitution with a note on the prescription.
• The higher co-payment applies only when a generic is listed in the same strength and pack size.
• Since 1 January 2024, a pharmacist may substitute a biological reference product with a less expensive biosimilar under Art. 52a HIA unless the prescriber requires the original for medical reasons.

Prices on the specialities list

Only medicines on the specialities list of the Federal Office of Public Health are paid by basic insurance. A generic price must undercut the originator by a margin that depends on the originator's Swiss turnover: the larger the market volume, the larger the required gap.

Authorisation by Swissmedic and listing on the specialities list are two separate procedures at two authorities. This directory shows the authorisation status, not prices. Our sibling site swissreimbursement.com carries the specialities list data with prices and limitations.

Biosimilars may also be listed on the specialities list. Since 1 January 2024, Art. 52a HIA permits a pharmacy to substitute a biological reference product with a less expensive biosimilar unless the prescriber requires the original for medical reasons.