24 January 2018 - - Thousand Oaks, California-based human therapeutics developer Amgen (NASDAQ: AMGN) and Dublin, Ireland-based specialty pharmaceutical company Allergan plc. (NYSE: AGN) have received marketing authorization from the European Commission (EC) for MVASI (biosimilar bevacizumab), the companies said.
MVASI is the first biosimilar bevacizumab approved by the EC, and is approved in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer.
It is approved 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.
Additionally, it is approved 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 EC approved MVASI based on a comprehensive data package that demonstrated MVASI and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety, and immunogenicity between the products.
Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the European Union. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
Allergan is a global pharmaceutical company focused on developing, manufacturing and commercializing branded pharmaceuticals, devices, and biologic products for patients around the world.
The company markets a portfolio of products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.