Biosimilars approved and marketed in Germany

Biosimilars/General | Posted 23/11/2012 post-comment0 Post your comment

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.

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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

Product name Active ingredient Therapeutic area Company Reference product Originator company
Abseamed$ epoetin alpha Anaemia
Cancer
Chronic kidney failure
Medice Arzneimittel Pütter Erypo Janssen-Cilag
Binocrit$ epoetin alpha Anaemia
Cancer
Chronic kidney failure
Sandoz   Erypo Janssen-Cilag
Biograstim* filgrastim Cancer
Hematopoietic stem cell transplantation
Neutropenia
CT Arzneimittel Neupogen Amgen
Epoetin alpha Hexal$ epoetin alpha Anaemia
Cancer
Chronic kidney failure
Hexal Erypo Janssen-Cilag
Filgrastim Hexal# filgrastim Cancer
Hematopoietic stem cell transplantation
Neutropenia
Hexal Neupogen Amgen
Nivestim filgrastim Cancer
Hematopoietic stem cell transplantation
Neutropenia
Hospira Neupogen Amgen
Omnitrope somatropin Pituitary dwarfism
Prader-Willi syndrome
Turner syndrome
Sandoz Genotropin Genentech/ Pfizer
Ratiograstim* filgrastim Cancer
Hematopoietic stem cell transplantation
Neutropenia
Ratiopharm Neupogen Amgen
Retacrit@ epoetin zeta Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure
Hospira Erypo Janssen-Cilag
Silapo@ epoetin zeta Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure
Stada Erypo Janssen-Cilag
Tevagrastim* filgrastim Cancer
Hematopoietic stem cell transplantation
Neutropenia
Teva Neupogen Amgen
Zarzio# filgrastim Cancer
Hematopoietic stem cell transplantation
Neutropenia
Sandoz Neupogen Amgen

* 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.

Related articles

Originator biologicals approved and marketed in Germany

Biosimilars approved and marketed in The Netherlands

Biosimilars approved in Europe

Biosimilars approved and marketed in Belgium

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Source: EMA, vfa

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