Marketing authorisation is issued once EMA’s European Assessment Committee CHMP (Committee for Medicinal Products for Human Use), in which CBG-MEB is represented, has scientifically assessed the efficacy, safety and quality of the medicinal product according to EMA guidelines.
The first biosimilar, somatropin (Omnitrope), was approved for marketing in The Netherlands by CBG in 2006. To date 12 biosimilars have been approved for marketing in The Netherlands, see Table 1.
| Product name
|
Generic name
|
Therapeutic area
|
Authorisation date
|
Presentation
|
Company
|
| Abseamed
|
epoetin alfa
|
Chronic kidney failure
Anaemia
Cancer
|
28 Aug 2007
|
Solution for injection, pre-filled syringe:
1,000 IU/0.5 mL 10,000 IU/1.0 mL
2,000 IU/1.0 mL
20,000 IU/0.5 mL
3,000 IU/0.3 mL
30,000 IU/0.75 mL
4,000 IU/0.4 mL
40,000 IU/1.0 mL
5,000 IU/0.5 mL
6,000 IU/0.6 mL
7,000 IU/0.7 mL
8,000 IU/0.8 mL
9,000 IU/0.9 mL
|
Medice Arzneimittel Pütter GmbH & Co KG
|
| Binocrit
|
epoetin alfa
|
Chronic kidney failure
Anaemia
Cancer
|
28 Aug 2007
|
Solution for injection, pre-filled syringe:
1,000 IU/0.5 mL
10,000 IU/1.0 mL
2,000 IU/1.0 mL
3,000 IU/0.3 mL
4,000 IU/0.4 mL
5,000 IU/0.5 mL
7,000 IU/0.7 mL
8,000 IU/0.8 mL
9,000 IU/0.9 mL
|
Sandoz GmbH
|
| 1 Oct 2009
|
20,000 IU/0.5 mL
30,000 IU/0.75 mL
40,000 IU/1.0 mL
|
| Biograstim
|
filgrastim
|
Neutropenia Haematopoietic stem cell transplantation
Cancer
|
15 Sep 2008
|
Solution for injection/infusion, prefilled syringe:
30 mIU/0.5 mL
48 mIU/0.8 mL
|
CT Arzneimittel GmbH
|
| Epoetin alfa Hexal
|
epoetin alfa
|
Chronic kidney failure
Anaemia
Cancer
|
28 Aug 2007
|
Solution for injection, prefilled syringe:
1,000 IU
10,000 IU
2,000 IU
3,000 IU
4,000 IU
5,000 IU
6,000 IU
7,000 IU/0.7 mL
8,000 IU
9,000 IU/0.9 mL
|
Hexal AG
|
| 1 Oct 2009
|
20,000 IU/0.5 mL
30,000 IU/0.75 mL
40,000 IU/1.0 mL
|
| Filgrastim Hexal
|
filgrastim
|
Neutropenia
Haematopoietic stem cell transplantation Cancer
|
06 Feb 2009
|
Solution for injection/infusion, pre-filled syringe:
30 mIU
48 mIU
|
Hexal AG
|
| Filgrastim ratiopharm
|
filgrastim
|
Neutropenia
Haematopoietic stem cell transplantation
Cancer
|
17 Sep 2008
|
Solution for injection or infusion:
30 mIU/0.5 mL
48 mIU/0.8 mL
|
Ratiopharm GmbH
|
| Nivestim
|
filgrastim
|
Neutropenia
Haematopoietic stem cell transplantation
Cancer
|
08 Jun 2010
|
Solution for injection:
120 µg/0.2 mL
300 µg/0.5 mL
480 µg/0.5 mL
|
Hospira UK Limited
|
| Omnitrope
|
somatropin
|
Turner syndrome
Pituitary dwarfism syndrome
Prader-Willi syndrome
|
12 Apr 2006
|
Powder and solvent for solution for injection:
1.3 mg/mL
5 mg/mL
|
Sandoz GmbH
|
| 20 Apr 2007
|
Solution for injection:
5 mg/mL
|
| 21 Sep 2007
|
10 mg/mL
|
| 16 Jun 2011
|
15 mg/mL
|
| Ratiograstim
|
filgrastim
|
Neutropenia
Haematopoietic stem cell transplantation
Cancer
|
17 Sep 2008
|
Solution for injection or infusion:
30 mIU/0.5 mL
48 mIU/0.8 mL
|
Ratiopharm GmbH
|
| Retacrit
|
epoetin zeta
|
Anaemia
Chronic kidney failure
Autologous blood transfusion
Cancer
|
18 Dec 2007
|
Solution for injection in prefilled syringe:
3,333 IU/mL
10,000 IU/mL
40,000 IU/mL
|
Hospira UK Limited
|
| Tevagrastim
|
filgrastim
|
Neutropenia
Haematopoietic stem cell transplantation
Cancer
|
17 Sep 2008
|
Solution for injection or infusion:
30 mIU/0.5 mL
48 mIU/0.8 mL
|
Teva Generics GmbH
|
| Zarzio
|
filgrastim
|
Neutropenia
Haematopoietic stem cell transplantation
Cancer
|
06 Feb 2009
|
Solution for injection (prefilled syringe):
30 MU/1 mL (0.3 mg/mL)
48 MU/1.6 mL (0.3 mg/mL)
|
Sandoz GmbH
|
| mIU = milli international unit; MU = million units.
|
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