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Biosimilars approved and marketed in The Netherlands Posted 01/06/2012

Last updated: 1 June 2012

The Dutch Medicines Evaluation Board (MEB) – College ter Beoordeling van Geneesmiddelen (CBG) – is responsible for the approval of marketing authorisation of medicinal products including biosimilars in The Netherlands.

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.

Table 1: Biosimilars approved and marketed in The Netherlands

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.

Related article

Biosimilars approved in Europe

Source: CBG-MEB

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