Biosimilars approved and marketed in The Netherlands

Biosimilars/General | Posted 01/06/2012 post-comment0 Post your comment

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.

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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

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Source: CBG-MEB

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