Biosimilars approved and marketed in Germany

Published: 2013-01-30

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

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

Source: www.gabionline.net

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