Biosimilars are biological drugs that are highly similar to another biological medicine, the so-called originator. The biosimilars have no clinically meaningful differences to the originator medicine in terms of quality, safety and efficacy. Manufacturers can produce biosimilars once the patent for the originator has expired. Therefore, they often are cheaper. To save money, clinicians are encouraged to switch their patients from the originator medicine to a biosimilar. However, biosimilars are bio-similar, not bio-identical. Thus, a patient might show intolerances to a biosimilar but not the originator. Clinicians can prescribe the originator or a biosimilar product. In addition, pharmacies are obliged to dispense the cheapest alternative for any active ingredient (= aut idem rule), unless a substitution was excluded by the clinician or the G-BA.
On 19 November 2021, the G-BA approved a specific overview of the interchangeability of biologics in Annex VIIa of the Drug Directive. The aim of this overview is to support clinicians in prescribing the most economic biological. In addition, clinicians can also prescribe biosimilars that are already available, even if they are not yet listed.
Annex VIIa (preliminary version) lists all approved biologicals that are biotechnologically produced and for which there is
- at least one biosimilar or
- several originals and therefore several reference products.
Currently, the list covers 26 biotechnologically produced active ingredients and the associated original products (reference products) as well as the biosimilars.
The G-BA will continuously update the overview.
This overview targets only prescribing by clinicians and does not apply to the aut idem substitution in pharmacies. The G-BA will make a separate resolution on this by August 2022 at the latest.
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