US clears first biosimilar cancer treatment with Amgen's Avastin biosimilar Mvasi

The FDA announced Thursday that it approved Amgen's Mvasi (bevacizumab-awwb) as a biosimilar version to Roche's Avastin (bevacizumab) for multiple cancer types, making it the first biosimilar approved in the US for the treatment of cancer. Specifically, Mvasi is indicated for certain adult patients with metastatic colorectal cancer, non-squamous non-small-cell lung cancer (NSCLC), glioblastoma, metastatic renal cell carcinoma and cervical cancer. 

The agency noted that similar to Avastin, the labeling for Mvasi includes a boxed warning about an increased risk of gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal haemorrhage. 

According to the FDA, approval was based on review of evidence that included structural and functional characterisation, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data "that demonstrate Mvasi is biosimilar to Avastin." However, the agency noted that Mvasi was not approved as an interchangeable product. 

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FDA Commissioner Scott Gottlieb said "we'll continue to work to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA's rigorous gold standard for safety and effectiveness." In remarks made earlier this year on the issue of drug pricing in the US, Gottlieb suggested the FDA needs to take steps to encourage the availability of lower cost alternatives, citing complex drugs and biosimilars as examples.

Avastin garnered sales of $6.7 billion last year. Pharmacy benefit manager Express Scripts estimated in 2013 that the US could be saving $250 billion over the next 10 years because of biosimilars. Amgen and partner Allergan have also filed Mvasi, formerly known as ABP 215, for regulatory approval in the EU. In 2015, the companies reported data from a Phase III trial in which Mvasi demonstrated clinical equivalence to Avastin in adults with advanced non-squamous NSCLC. 

Meanwhile, the US Supreme Court in June unanimously overturned a lower court decision that had prevented Novartis from selling its biosimilar version of Amgen's Neupogen (filgrastim) until 180 days after gaining FDA approval. The high court also decided that patent holders could not force biosimilar manufacturers to provide information about their products. For related analysis, see ViewPoints: Amgen loses biosimilar battle, but not the war.

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