Biosimilars are inexpensive imitation drugs of expensive biological drugs. Now, Swissmedic has confirmed that the two types of drugs are comparable in terms of efficacy and safety. The Federal Office of Public Health (FOPH) therefore intends to promote the dispensing of biosimilars in the course of ongoing revision projects.
When the patent and documentation protection of original drugs expires, the hour of the generics and biosimilar strikes. Generics are cheaper imitation products of chemical active ingredients, biosimilars those of biological active ingredients. Until now, it had only been proven that generics were in no way inferior to the original products in terms of efficacy and safety. For biosimilars, this has only now been demonstrated.
| List of measures, for submission to the Federal Council |
|---|
| – Better identification of biosimilars: Biosimilars and related reference products should be better identified through labeling in the list of specialties. |
| – Removal of false incentives and hurdles: The sales share for biosimilars should now be the same as for more expensive reference products. In addition, it should no longer be necessary to obtain approval from the health insurance company to switch to biosimilars. |
| – Rewarding dispensing and substitution: The share of drug costs to be paid by the insured themselves should be lower for cheaper biosimilars than for the reference drug. |
Swissmedic is responsible for the approval of biosimilars in Switzerland. With the approval of a biosimilar, Swissmedic now confirms that the minor differences in the manufacturing processes do not affect the safety and efficacy of the biosimilar compared to the reference product. This was also confirmed by a Health Technology Assessment commissioned by the Federal Office of Public Health. For reimbursement by health insurance, this means that interchangeability between reference preparations and lower-cost biosimilars is guaranteed. So far, biosimilars have been used very cautiously in Switzerland. However, since expensive biologics account for a large share of the rising cost of pharmaceuticals, the potential for savings is enormous. The FOPH therefore plans to promote the use of biosimilars as part of the ongoing revision projects for the Health Care Benefits Ordinance and Health Insurance Ordinance.
Source: www.bag.admin.ch/bag/de/home/das-bag/aktuell/news/news-22-06-2023.html (last accessed on 14.08.2023)
InFo NEUROLOGIE & PSYCHIATRIE 2023; 21(4): 36
