Biosimilars approved and marketed in Germany

Last updated: 23 November 2012 

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing authorization, of medicinal products, including biosimilars, in Germany.

The BfArM authorizes finished medicinal products on the basis of the German Medicines Act (Arzneimittelgesetz, AMG). In the course of these licensing procedures it reviews the proof of efficacy, safety, and adequate pharmaceutical quality of the finished medicinal products.

Licenses are limited to five years. Renewals are granted upon application and after new evaluation. BfArM must be notified of variations to already licensed medicinal products.  Major variations can only be implemented after authorization by BfArM.

To date 12 biosimilars (Table 1) have been approved for marketing in Germany.

Table 1: Biosimilars approved and marketed in Germany

* Biograstim, Ratiograstim and Tevagrastim are one biosimilar with three brand names.
^# Filgrastim Hexal and Zarzio are one biosimlar with two brand names.
^$ Abseamed, Binocrit and Epoetin alfa Hexal are one biosimilar with three brand names.
^@ Retacrit and Silapo are one biosimilar with two brand names.

Biosimilars with several brand names are produced in one and the same manufacturing plant of the generics producer, and are therefore identical among each other and substitutable among each other.

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Source: www.gabionline.net

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