Last updated: 14 December 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 biologicals, 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. The BfArM must be notified of variations to already licensed medicinal products. Major variations can only be implemented after authorization by the BfArM.
To date 14 originator biologicals (Table 1) have been approved for marketing in Germany.
Table 1: Biologicals approved and marketed in Germany
|
Product name |
Active ingredient |
Therapeutic area |
Cell line |
Company |
|
Aranesp |
darbepoetin alpha |
Anaemia |
Chinese hamster ovary (CHO) cells |
Amgen |
|
Biopoin* |
Epoetin theta |
Anaemia |
CHO cells |
CT Arzneimittel/Merckle Biotec |
|
Eporatio*# |
Epoetin theta |
Anaemia |
CHO cells |
Ratiopharm/Merckle Biotec |
|
Erypo |
epoetin alpha |
Anaemia |
CHO cells |
Janssen-Cilag/Johnson & Johnson |
|
Genotropin |
somatropin |
Growth hormone deficiency |
E. coli |
Genentech/Pfizer |
|
Granocyte |
lenograstim |
Neutropenia |
CHO cells |
Chugai Pharma |
|
Humatrope |
somatropin |
Growth hormone deficiency |
E. coli |
Eli Lilly |
|
Mircera |
Methoxy polyethylene glycol-epoetin beta |
Anaemia |
CHO cells |
Roche |
|
Neorecormon |
epoetin beta |
Anaemia |
CHO cells |
Roche |
|
Neulasta |
pegfilgrastim |
Cancer |
E. coli |
Amgen |
|
Neupogen |
filgrastim |
Cancer |
E. coli |
Amgen |
|
Norditropin |
somatropin |
Growth hormone deficiency |
E. coli |
Novo Nordisk |
|
Nutropinaq |
somatropin |
Pituitary dwarfism |
E. coli |
Genentech/Ipsen |
|
Saizen |
somatropin |
Growth hormone deficiency |
Mouse cells C127 |
Merck Serono |
|
Zomacton |
somatropin |
Growth hormone deficiency |
E. coli |
Ferring |
|
*Biopoin and Eporatio are one product with two brand names, they are produced in one and the same manufacturing plant, are identical between each other and substitutable between each other. |
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Related articles
Biosimilars approved and marketed in Germany
Biosimilars approved and marketed in The Netherlands
Biosimilars approved in Europe
Source: www.gabionline.net
