Originator biologicals approved and marketed in Germany

Biosimilares/General | Posted 14/12/2012 post-comment0 Post your comment

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.

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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. 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
Cancer
Chronic kidney failure
Chinese hamster ovary (CHO) cells Amgen
Biopoin* Epoetin theta Anaemia
Cancer
Chronic kidney failure
CHO cells CT Arzneimittel/Merckle Biotec
Eporatio*# Epoetin theta Anaemia
Cancer
Chronic kidney failure
CHO cells Ratiopharm/Merckle Biotec
Erypo epoetin alpha Anaemia
Cancer
Chronic kidney failure
CHO cells Janssen-Cilag/Johnson & Johnson
Genotropin somatropin Growth hormone deficiency
Prader-Willi syndrome
Turner syndrome
E. coli Genentech/Pfizer
Granocyte lenograstim Neutropenia
Haematopoietic stem cell transplantation
Cancer
CHO cells Chugai Pharma
Humatrope somatropin Growth hormone deficiency
Turner syndrome
E. coli Eli Lilly
Mircera Methoxy polyethylene glycol-epoetin beta Anaemia
Chronic kidney failure
CHO cells Roche
Neorecormon epoetin beta Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure
CHO cells Roche
Neulasta pegfilgrastim Cancer
Neutropenia
E. coli Amgen
Neupogen filgrastim Cancer
Haematopoietic stem cell transplantation
Neutropenia
E. coli Amgen
Norditropin somatropin Growth hormone deficiency
Noonan syndrome
Turner syndrome
E. coli Novo Nordisk
Nutropinaq somatropin Pituitary dwarfism
Turner syndrome
E. coli Genentech/Ipsen
Saizen somatropin Growth hormone deficiency Mouse cells C127 Merck Serono
Zomacton somatropin Growth hormone deficiency
Turner syndrome
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.
#Eporatio was initially intended to be submitted as a biosimilar application to EMA, but finally was approved via a ‘complete and independent application’ according to the European Public Assessment Report.

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Biosimilars approved in Europe

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Source: EMA, vfa

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