Originator biologicals approved and marketed in Germany

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Originator biologicals approved and marketed in Germany

Biosimilars/General | Posted 14/12/2012 0 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.

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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Source: EMA, vfa