LONDON, Jan 19 (APM) - Roche's big-selling Avastin looks under threat in Europe after approval of Amgen/Allergan's Mvasi, the first approved biosimilar of bevacizumab in the EU.
Amgen and Allergan said in a joint late Thursday statement
that approval is for a large number of cancers.
It was recommended for approval by the European Medicines Agency's CHMP technical committee in November (APMHE 55556
EU approval comes four months after Mvasi was approved in the U.S., where it became the first approved cancer biosimilar. (APMHE 54712
Head of research and development at Amgen Dr Sean Harper said: "The European Commission's approval of Mvasi marks a significant milestone for both Amgen and the oncology community, providing a biosimilar for a medicine which is used across multiple types of cancer.
"Mvasi is the first targeted cancer biosimilar from Amgen's portfolio approved in Europe, underscoring our commitment to delivering high-quality medicines that address some of the most serious illnesses."
David Nicholson, chief research development officer at Allergan, said: "Mvasi is the first product from our collaboration with Amgen to receive marketing authorisation from the European Commission, highlighting the success of our joint commitment to developing cancer biosimilars."
Amgen and Allergan are working on the development and commercialisation of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC.
Profit pressures for Roche
Roche’s chief executive warned earlier this week of profit pressures because more drugs are set to lose patent protection. (APMHE 56439
In an interview with the Financial Times, Severin Schwan said the Swiss pharma is facing increasing biosimilar competition.
Copies of its breast cancer drug Herceptin (trastuzumab) and its blood cancer drug MabThera (rituximab) were approved last year and Avastin is now facing similar biosimilar competition.
Roche reported in October 2017 third-quarter results showing Avastin was its third biggest-selling drug at 1.6 billion Swiss francs (1.36 billion euros), 4% down on the same period in 2016.