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Monday 22 October 2018
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First Avastin biosimilar candidate recommended for European approval

Amgen and Allergan have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation of ABP 215, a biosimilar to Avastin® (bevacizumab).


ABP 215 has been recommended for approval for the treatment of 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; 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.

ABP 215 has the potential to provide healthcare professionals and appropriate patients across Europe access to high-quality, targeted cancer therapy,” said 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.”

Amgen and Allergan are committed to developing high-quality biosimilars with a robust analytic and clinical package. The Marketing Authorisation Application for ABP 215 was based on a comprehensive data package that demonstrated ABP 215 and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products. Clinical studies included results from a Phase III trial in patients with non-squamous NSCLC.

"This positive opinion underscores our commitment with Amgen to bringing biosimilars to market to help patients with difficult-to-treat cancers," said David Nicholson, chief research and development officer at Allergan. “We are encouraged by the progress Amgen and Allergan have made in developing biosimilars in critical disease areas and look forward to providing important medicines to patients in the future.”

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralised marketing authorisation will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.

In September 2017, ABP 215 became the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, to be approved by the US Food and Drug Administration (FDA). It is approved in the US with the brand name MVASI™ (bevacizumab-awwb). Amgen and Allergan are collaborating on the development and commercialisation of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one of which has been approved by the EC.

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