Please login to the form below

Not currently logged in
Email:
Password:

Europe set to approve first Glivec generic

CHMP backs Teva version of Novartis' blockbuster cancer drug

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.

22nd October 2012

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Origins Insights

Our goal is to identify and embed transformational patient insights as a fundamental part of the drug development process. As...

Latest intelligence

How can we strike the right balance between familiarity and innovation when it comes to data presentation?
Following our webinar in March, Getting MedComms right: navigating the age of the amateur expert, we’re taking the time to respond to questions we were unable to answer during the...
Deep 6 AI: the smart software breathing new life into clinical trials
Fishawack Health interviews Wout Brusselaers, the Deep 6 AI CEO using artificial intelligence to solve one of the greatest barriers stagnating healthcare innovation—clinical trial recruitment and retention....
COVID-proof: How Teams are Creating Launch Intensity thru Adversity
Now that the game has changed, how are marketers shifting their launch behaviour? We've identified 5 common observations from effective teams....