Biosimilars approved and marketed in Belgium

The Federal Agency for Medicines and Health Products (FAMHP), formerly the Directorate-General for Medicinal Products of the Federal Public Service (FPS) Public Health, created in January 2007, is the official authority for medicines and health products in Belgium and is also responsible for authorising biosimilars in Belgium. This is carried out via the EU procedures (centralised, national, mutual recognition or decentralised) and following EMA guidelines for biosimilars.

In view of their complexity, biosimilars are not considered interchangeable in Belgium. FAMHP recommends that biosimilars not be prescribed by INN (International Non-proprietary Name). If the prescriber decides to switch from one to the other (originator/biosimilar; biosimilar/originator or biosimilar/biosimilar), then this must be done with the necessary follow-up and the modification must be recorded accurately. Substitution of biosimilars by the pharmacist without consulting the doctor is not allowed in Belgium.

The first biosimilar, somatropin (Omnitrope), was approved for marketing in Belgium by FAMHP in April 2007. To date five biosimilars are approved for marketing in Belgium, see Table 1.

Table 1: Biosimilars approved and marketed in Belgium

Product name	Generic name	Therapeutic area	Authorisation date	Presentation	Company
Binocrit	epoetin alfa	Chronic kidney failure Anaemia Cancer	14 Mar 2011	Solution for injection, prefilled 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 8,000 IU/0.8 mL	Sandoz
Omnitrope	somatropin	Turner syndrome Pituitary dwarfism Prader-Willi syndrome	20 Apr 2007 19 Sep 2007	Solution for injection, 1.5 mL cartridge: 3.3 mg/mL 6.7 mg/mL	Sandoz
Retacrit	epoetin zeta	Anaemia Chronic kidney failure Autologous blood transfusion Cancer	18 Dec 2007	Solution for injection, prefilled syringe: 10,000 IU/1 mL 1,000 IU/0.3 mL 20,000 IU/0.5 mL 2,000 IU/0.6 mL 30,000 IU/0.75 mL 3,000 IU/0.9 mL 40,000 IU/1.0 mL 4,000 IU/0.4 mL 5,000 IU/0.5 mL 6,000 IU/0.6 mL 8,000 IU/0.8 mL	Hospira
Tevagrastim	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 48 mIU/0.5 mL	Teva
Zarzio	filgrastim	Neutropenia Haematopoietic stem cell transplantation Cancer	06 Feb 2009	Solution for injection/infusion, prefilled syringe: 30 mIU/0.5 mL 48 mIU/0.5 mL	Sandoz

IU: international units; mIU: milli-international units; mL: millilitre; mg: milligram
Source: FAMHP

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Source: www.gabionline.net

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