Biosimilars approved and marketed in Belgium Posted 18/05/2012
Last updated: 18 May 2012 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 [1]. 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 14 Mar 2011
Solution for injection, prefilled syringe: Sandoz Omnitrope somatropin
Turner syndrome 20 Apr 2007 19 Sept 2007
Solution for injection, 1.5 mL cartridge: Sandoz Retacrit epoetin zeta
Anaemia 18 Dec 2007
Solution for injection, prefilled syringe: Hospira Tevagrastim filgrastim
Neutropenia 15 Sept 2008
Solution for injection/infusion, prefilled syringe: Teva Zarzio filgrastim
Neutropenia 06 Feb 2009
Solution for injection/infusion, prefilled syringe: Sandoz
IU: international units; mIU: milli-international units; mL: millilitre; mg: milligram 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
8,000 IU/0.8 mL
Pituitary dwarfism
Prader-Willi syndrome
3.3 mg/mL 6.7 mg/mL
Chronic kidney failure
Autologous blood transfusion
Cancer
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
Haematopoietic stem cell transplantation
Cancer
30 mIU/0.5 mL
48 mIU/0.8 mL
48 mIU/0.5 mL
Haematopoietic stem cell transplantation
Cancer
30 mIU/0.5 mL
48 mIU/0.5 mL
Source: FAMHP
Source: FAMHP