FDA Approves Amgen’s Avastin Biosimilar

On Sep. 14, 2017, FDA approved Mvasi (bevacizumab-awwb), Amgen’s biosimilar to Roche’s Avastin (bevacizumab), for treating multiple types of cancer. This marks the first biosimilar approved in the United States for cancer, according to FDA.

Avastin, approved by FDA in February 2004, is one of Roche’s top-selling drugs, achieving 2016 sales of CHF 6.78 billion (US$7.06 billion).

Mvasi is approved for treating metastic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer. Like Avastin, the labeling for Mvasi contains a boxed warning to alert health care professionals and patients about an increased risk of holes in the stomach and intestines (gastrointestinal perforations); surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding (hemorrhage).

“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb, MD, in an agency press release. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet [FDA’s] rigorous gold standard for safety and effectiveness.”

"MVASI is the first product from our collaboration with Amgen to be approved by [FDA] and underscores our joint commitment to bring cancer biosimilars to market to help patients," said David Nicholson, chief research and development officer at Allergan, in a company press release. "We are committed to developing safe and effective therapies in critical disease areas, and MVASI is leading the way for additional oncology biosimilars from Amgen and Allergan."

Amgen and Allergan's bevacizumab biosimilar is also undergoing review by the European Medicines Agency, following a marketing authorization application submitted in December 2016. The companies are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by FDA, including MVASI.

Amgen and Allergan (then Watson Pharmaceuticals) formed the collaboration in December 2011 to develop and commercialize four oncology antibody biosimilar medicines on a worldwide basis. Under the agreement, Amgen has primary responsibility for developing, manufacturing, and initially commercializing the oncology antibody products. Allergan contributes up to $400 million in co-development costs over the course of development, including the provision of development support, and shares product development risks.

MVASI is a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors, according to Amgen.

Source: FDA, Amgen