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 products by biosimilars and incentivize patients to choose generics and biosimilars when available.
A. Background
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 products in Switzerland.
As per the Federal Council, generic and biosimilar pharmaceutical products are not used as often in Switzerland as in comparable developed countries, which results in higher costs for mandatory health insurance. Among the aims of the changes is to decrease the costs of health insurance by encouraging the replacement of original or reference products by generics and biosimilars.
The latest developments include a change of the relevant regulatory environment on interchangeability of biosimilars and more restrictive rules on pricing and reimbursement of both generics and biosimilars.
The bill also includes measures related to reimbursement 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 this Newsflash.
B. Interchangeability of Biosimilars with Reference Products
