Novartis’ Glivec (imatinib) will soon face generic competition in Europe after Teva’s copycat version of the blockbuster cancer drug was recommended for approval.
The CHMP issued a positive opinion for Teva’s Imatinib Teva for the treatment of leukaemia after it was satisfied the generic product could prove bioequivalence with Novartis’ therapy.
However, a pharmacovigilance plan for Imatinib Teva will be implemented as part of the marketing authorisation.
Imatinib Teva was recommended for European approval for paediatric patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic and myeloid leukaemia (CML) patients for whom bone marrow transplantation is not first line treatment.
It was also backed to treat paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis, and adult patients with Ph+ CML in blast crisis.
Glivec was Novartis’ second biggest-selling drug of 2011, taking in $4.66bn during the year. Its approved indications included gastrointestinal stromal tumours (GIST), where it is the current standard of care. Its licence in this indication was widened its Europe earlier this year.