European Commission Approves First Biosimilar Bevacizumab, Mvasi

Amgen and Allergan announced on Thursday that the European Commission (EC) has granted a marketing authorization to Mvasi, a biosimilar bevacizumab referencing Avastin, for the treatment of certain cancers.

The EC approval grants a centralized marketing authorization for the drug, with unified labeling, in the 28 members of the European Union. European Economic Area nations (Norway, Iceland, and Liechtenstein) will make regulatory decisions concerning the drug based on the EC’s approval. The marketing authorization follows a positive opinion on the biosimilar granted by the European Medicines Agency’s Committee for Medicinal Products for Human Use granted in November 2017.

"The European Commission's approval of Mvasi marks a significant milestone for both Amgen and the oncology community, providing a biosimilar for a medicine which is used across multiple types of cancer," said Sean E. Harper, MD, executive vice president of research and development at Amgen, in a statement. "Mvasi is the first targeted cancer biosimilar from Amgen's portfolio approved in Europe, underscoring our commitment to delivering high-quality medicines that address some of the most serious illnesses."

European regulatory clearance for Mvasi follows the FDA’s approval of the drug in September 2017, based on a comprehensive data package including analytical, pharmacokinetic, and clinical data that demonstrated that the biosimilar and its reference are highly similar, with no clinically meaningful differences in terms of efficacy, safety, and immunogenicity. Clinical data presented to the FDA included results of a phase 3 study of Mvasi in patients with non—small-cell lung cancer.

Despite these 2 approvals, the timing of Mvasi’s launch remains unclear. In the United States, ongoing patent litigation continues to delay commercial availability of the biosimilar; Genentech, maker of the reference Avastin, recently sued Amgen over Mvasi in a Delaware court, saying that the biosimilar developer did not properly exchange information related to the drug as required under the Biologics Price Competition and Innovation Act, and that Amgen refused to negotiate the scope of litigation concerning alleged patent infringement. Meanwhile, Amgen has filed suit in a California court, seeking a judgment that Mvasi did not and will not infringe on 27 patents covering the reference Avastin.