Allergan’daki Ar Ge sorumlusu David Nicholson , “Mvasi, Amgen ile yaptığımız işbirliğiyle Avrupa Komisyonu’ndan pazarlama izni aldığımız ilk üründür ve onkolojik biyobenzerler geliştirme konusundaki ortak taahhüdümüzün başarısını vurgulamaktadır” dedi.
The European Commission (EC) has granted marketing authorization for Mvasi (biosimilar bevacizumab), from US biotech major Amgen (Nasdaq: AMGN) and Ireland-incorporated Allergan (NYSE: AGN).
The approval comes after a positive recommendation from the European Medicines Agency’ appraisal unit in November and follows approval from the US Food and Drug Administration in September last year, making it the first biosimilar in the USA of Swiss pharma giant Roche’s (ROG: SIX) blockbuster cancer drug Avastin.
Avastin retains patent exclusivity until 2019 in the USA and until 2022 in Europe. Shortly after Amgen received FDA approval for Mvasi, Roche subsidiary a Genentech and Amgen filed competing lawsuits regarding patent infringement.
Mvasi is also the first biosimilar bevacizumab cleared by the EC and is approved for the treatment of certain types of cancers, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix.
“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,” said Sean Harper, executive vice president of R&D at Amgen. “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,” Dr Harper added.
“Mvasi is the first product from our collaboration with Amgen to receive marketing authorization from the European Commission, highlighting the success of our joint commitment to developing cancer biosimilars,” said David Nicholson, chief research and development officer at Allergan. “We look forward to our continued work with Amgen and to providing important medicines to patients in the future.”
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC.
