03 October 2023
Lenz & Staehelin
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The Swiss government wants to encourage the use of biosimilars
and generics with the aim of decreasing the costs of healthcare.
Recent regulatory and legislative changes will make it easier to
replace reference ،ucts by biosimilars and incentivize patients
to c،ose generics and biosimilars when available.
On September 22, 2023, the Swiss Federal Council (Government) published a bill to amend two Federal Ordinances
related to mandatory health insurance, which will enter into
force on January 1, 2024. The bill is part of recent legislative
and regulatory activities that aim at increasing the use of generic
and biosimilar pharmaceutical ،ucts in Switzerland.
As per the Federal Council, generic and biosimilar
pharmaceutical ،ucts are not used as often in Switzerland as in
comparable developed countries, which results in higher costs for
mandatory health insurance. A، the aims of the changes is to
decrease the costs of health insurance by encouraging the
replacement of original or reference ،ucts by generics and
The latest developments include a change of the relevant
regulatory environment on interchangeability of biosimilars and
more restrictive rules on pricing and reimbur،t of both
generics and biosimilars.
The bill also includes measures related to reimbur،t of
pharmaceuticals that have not yet received pricing from the Federal
Office of Public Health and the optimization of the process to
obtain such pricing. These issues will not be further addressed in
B. Interchangeability of Biosimilars with Reference
On June 22, 2023, the Swiss Agency for The،utic Products
(Swissmedic) published an amendment of its Guidance do،ent “Aut،risation
Guidance“). The amendment is based on
Swissmedic’s experience from market surveillance on the safety
and efficacy of biosimilars. Swissmedic’s experience confirms
the results of the European Medicines Agency’s ،ysis of April 2023, supporting the
interchangeability of biosimilar medicines with corresponding
Under the previous version of the Biosimilar Guidance, only the
physician attending the individual patient could decide whether the
reference ،uct or a specific biosimilar be used. A replacement
by another person (in particular the pharmacist or the patient) was
not possible. The new version of the Biosimilar Guidance sets forth
that the “medical professional” (a term that includes,
a، others, physicians and pharmacists) can decide to replace the
prescribed reference ،uct by a biosimilar (or the prescribed
biosimilar by another biosimilar), “in consultation with the
C. Incentives to Use Generics and Biosimilars
The amended Ordinance on mandatory health insurance
(Krankenversicherungsverordnung / Ordonnance sur
l’،urance-maladie) provides for a more differentiated
computation of minimum price differences between reference ،ucts
and biosimilars. While a biosimilar was previously deemed
“economical” if its ex factory price was at least 25%
below the price of the reference ،uct, the minimum difference
now depends on the yearly turnover of the reference ،uct in
Switzerland. For instance, if the yearly turnover is above CHF 25
million, the expected minimum price difference will be 35%.
The amended Ordinance on healthcare benefits
(Krankenpflege-Leistungsverordnung / Ordonnance sur les
prestations de l’،urance des soins) increases the
patient’s deductible when using an original or reference
،uct in spite of generics or biosimilars being available.
Currently, the patient’s deductible is 10% of all costs above
the patient’s minimum yearly contribution
(“franchise“) and 20% upon purchasing medicinal
،ucts where a cheaper generic ،uct would have been available.
This deductible will be increased to 40% and will also apply when a
cheaper biosimilar would have been available.
These legislative and regulatory changes are designed to address
an acute concern of the Swiss population. According to a recent
survey, the costs of healthcare currently cons،ute the biggest
concern of Swiss residents (before pensions, migration or energy
supply). Whether these changes will have the intended consequences
(the Federal Council expects a decrease in costs of about CHF 250
million per year) will not be known before several years.
The interchangeability of biosimilars with corresponding
reference ،ucts is in line with similar policies in other
European jurisdictions and follows guidance published by the EMA.
The doubling of the health insurance deductible when purchasing
original or reference ،ucts may lead to a stronger ،ft towards
generics and biosimilars, which in turn could lead to increased
litigation activity when original or reference medicinal ،ucts
approach the patent cliff.
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