Production & Manufacturing
Process & Production

EMA’s CHMP recommends Amgen and Allergan’s ABP 215 to treat certain types of cancer

PBR Staff Writer Published 13 November 2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended to approve ABP 215 for the treatment of certain types of cancer.

ABP 215, which is a biosimilar to Avastin (bevacizumab), has been recommended for marketing authorization to treat certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum

It is also recommended to be used with paclitaxel for metastatic breast cancer, platinum-based chemotherapy for unresectable advanced and metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) and erlotinib for unresectable advanced advanced and metastatic or recurrent non-squamous NSCLC.

CHMP has also reccommeded ABP 215 to be used with interferon alfa-2a for advanced and/or metastatic renal cell cancer, 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.

In addition, ABP 215 in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan can be used for persistent, recurrent, or metastatic carcinoma of the cervix.

CHMP has recommended ABP 215 based on a comprehensive data package, which showed ABP 215 and bevacizumab are similar and with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products.

European Commission (EC) will now assess the CHMP positive opinion to approve ABP 215, allowing to market the drug in the 28 countries.

In December 2011, Amgen and Allergan have collaborated to develop and commercialize four oncology antibody biosimilar medicines.

Allergan chief research and development officer David Nicholson said: "This positive opinion underscores our commitment with Amgen to bringing biosimilars to market to help patients with difficult-to-treat cancers.”