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EMA approves first generic imatinib Posted 09/11/2012

EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2012 that the agency had approved a generic version of imatinib.

Imatinib is a protein kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs, and which is used to treat leukaemia. The drug (Imatinib Teva) is a generic of Swiss Pharma Giant Novartis’s blockbuster Glivec, which had sales of US$1.08 billion in 2010 and has been authorized in the EU since 7 November 2001.

The CHMP adopted a positive opinion, recommending the granting of a marketing authorization within the EU for 100 mg and 400 mg film-coated tablets and capsules of the Israeli generics giant Teva Pharmaceutical Industries (Teva) Imatinib Teva. The decision was reached after studies demonstrated the satisfactory quality of Imatinib Teva, and its bioequivalence with the reference product Glivec.

EMA also announced that a pharmacovigilance plan for Imatinib Teva would be implemented as part of the marketing authorization.

Imatinib Teva is approved for the following indications:

  • Treatment of paediatric patients with newly diagnosed Philadelphia-chromosome (bcr‑abl)-positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment
  • Treatment of paediatric patients with Ph+ CML in chronic phase after failure of interferon‑alpha therapy, or in accelerated phase or blast crisis
  • Treatment of adult patients with Ph+ CML in blast crisis

Until 27 September 2012, according to EMA’s list of applications for new human medicines, the agency has 18 generics under review [1].

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1.  GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 9]. Available from: www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA

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Source: EMA

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