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

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Serviceplan Health & Life

We are your creative global lead agency, your Pan-European hub and your worldwide network....

Latest intelligence

Leveraging HCP Transparency Insights to Drive Future Customer Investments
EFPIA’s disclosure requirements present an opportunity to assess strategy and effectiveness...
How did pharma use Twitter at #ASCO16?
Each year, ASCO’s Annual Meeting brings together 30,000 oncology professionals from around the world, here we explore the #ASCO16 hashtag and how pharma utilised the channel during this year's event....
WHITE PAPER: How to engage with HCPs more effectively
Shrinking budgets and limitations on the time HCPs can spend with sales reps is making traditional engagement methods more and more ineffective. So, in order to reach the unreachable, pharma...

Infographics