The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given Amgen (NASDAQ: AMGN) and Allergan (NYSE: AGN) a positive opinion for the Marketing Authorisation of ABP 215, a biosimilar to Avastin (bevacizumab), Hospital Healthcare reported on Thursday.
ABP 215 has been recommended as a treatment for certain types of cancer, including: in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; and in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
It was also recommended as a treatment 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;
"ABP 215 has the potential to provide healthcare professionals and appropriate patients across Europe access to high-quality, targeted cancer therapy," commented Sean E Harper, MD, executive vice president of Research and Development at Amgen.
"The positive CHMP opinion for ABP 215 marks the first time a bevacizumab biosimilar has been recommended for approval in the European Union, which is an exciting milestone for Amgen."
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