Biosimilars approved and marketed in Germany

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Biosimilars approved and marketed in Germany

Biosimilars/General | Posted 23/11/2012 0 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.

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.

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Source: EMA, vfa