Originator biologicals approved and marketed in Germany

Published: 2013-02-27

Originator biologicals approved and marketed in Germany

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.

Related articles

Biosimilars approved and marketed in Germany

Biosimilars approved and marketed in The Netherlands

Biosimilars approved in Europe

Source: www.gabionline.net

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