Biosimilar Bevacizumab ABP 215 Gains Positive CHMP Opinion

Drug makers Amgen and Allergan announced on Friday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ABP 215, the companies’ bevacizumab biosimilar. CHMP recommended the biosimilar for approval for the treatment of multiple cancer indications.

"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, M.D., 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."

Allergan’s chief research and development officers, David Nicholson, also praised the milestone along the biosimilar’s approval pathway, saying, "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 positive CHMP opinion will next be reviewed by the European Commission (EC), which holds the final authority to approve medicines in the European Union. If the EC approves the drug, Amgen and Allergan will be granted a centralized marketing authorization that will be valid in the 28 current EU member states. Norway, Iceland, and Liechtenstein, as members of the European Economic Area, will also undertake their own independent assessments of the biosimilar based on the EC’s decision.

ABP 215 was also approved by the FDA in September 2017, and will be sold in the United States under the brand name Mvasi once it reaches the US marketplace. However, when Mvasi may reach patients remains unclear; Amgen is currently involved in patent litigation with the reference bevacizumab’s (Avastin) manufacturer, Genentech. In October, Amgen filed suit against Genentech in a California district court, seeking a judgment that ABP 215 did not infringe, and will not infringe, on 27 patents covering Avastin.