Biosimilars approved and marketed in The Netherlands

Biosimilars/General | Posted 01/06/2012 post-comment

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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
Binocrit	epoetin alfa	Chronic kidney failure Anaemia Cancer	1 Oct 2009	20,000 IU/0.5 mL 30,000 IU/0.75 mL 40,000 IU/1.0 mL	Sandoz GmbH
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
Epoetin alfa Hexal	epoetin alfa	Chronic kidney failure Anaemia Cancer	1 Oct 2009	20,000 IU/0.5 mL 30,000 IU/0.75 mL 40,000 IU/1.0 mL	Hexal AG
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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