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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 28 Aug 2007
Solution for injection, pre-filled syringe: Medice Arzneimittel Pütter GmbH & Co KG Binocrit epoetin alfa
Chronic kidney failure 28 Aug 2007
Solution for injection, pre-filled syringe: Sandoz GmbH 1 Oct 2009
20,000 IU/0.5 mL Biograstim filgrastim
Neutropenia Haematopoietic stem cell transplantation 15 Sep 2008
Solution for injection/infusion, prefilled syringe: CT Arzneimittel GmbH Epoetin alfa Hexal epoetin alfa
Chronic kidney failure 28 Aug 2007
Solution for injection, prefilled syringe: Hexal AG 1 Oct 2009
20,000 IU/0.5 mL Filgrastim Hexal filgrastim
Neutropenia 06 Feb 2009
Solution for injection/infusion, pre-filled syringe: Hexal AG Filgrastim ratiopharm filgrastim
Neutropenia 17 Sep 2008
Solution for injection or infusion: Ratiopharm GmbH Nivestim filgrastim
Neutropenia 08 Jun 2010
Solution for injection: Hospira UK Limited Omnitrope somatropin
Turner syndrome 12 Apr 2006
Powder and solvent for solution for injection: Sandoz GmbH 20 Apr 2007
Solution for injection: 21 Sep 2007 10 mg/mL 16 Jun 2011 15 mg/mL Ratiograstim filgrastim
Neutropenia 17 Sep 2008
Solution for injection or infusion: Ratiopharm GmbH Retacrit epoetin zeta
Anaemia 18 Dec 2007
Solution for injection in prefilled syringe: Hospira UK Limited Tevagrastim filgrastim
Neutropenia 17 Sep 2008
Solution for injection or infusion: Teva Generics GmbH Zarzio filgrastim
Neutropenia 06 Feb 2009
Solution for injection (prefilled syringe): Sandoz GmbH mIU = milli international unit; MU = million units. Related article
Anaemia
Cancer
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
Anaemia
Cancer
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
30,000 IU/0.75 mL
40,000 IU/1.0 mL
Cancer
30 mIU/0.5 mL
48 mIU/0.8 mL
Anaemia
Cancer
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
30,000 IU/0.75 mL
40,000 IU/1.0 mL
Haematopoietic stem cell transplantation Cancer
30 mIU
48 mIU
Haematopoietic stem cell transplantation
Cancer
30 mIU/0.5 mL
48 mIU/0.8 mL
Haematopoietic stem cell transplantation
Cancer
120 µg/0.2 mL
300 µg/0.5 mL
480 µg/0.5 mL
Pituitary dwarfism syndrome
Prader-Willi syndrome
1.3 mg/mL
5 mg/mL
5 mg/mL
Haematopoietic stem cell transplantation
Cancer
30 mIU/0.5 mL
48 mIU/0.8 mL
Chronic kidney failure
Autologous blood transfusion
Cancer
3,333 IU/mL
10,000 IU/mL
40,000 IU/mL
Haematopoietic stem cell transplantation
Cancer
30 mIU/0.5 mL
48 mIU/0.8 mL
Haematopoietic stem cell transplantation
Cancer
30 MU/1 mL (0.3 mg/mL)
48 MU/1.6 mL (0.3 mg/mL)
Source: CBG-MEB
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