FDA okays biosimilar for several cancers

While FDA has approved a handful of biosimilar drugs, the agency just approved the first biosimilar that treats a variety of types of cancer.

Bevacizumab-awwb (Mvasi, Amgen), the biosimilar of bevacizumab (Avastin, Genentech) has been approved to treat certain colorectal, lung, brain, kidney and cervical cancers.

Related: FDA clears second Remicade biosimilar

“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. “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 the FDA’s rigorous gold standard for safety and effectiveness.”

Mvasi can now be used to treat  metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment; metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen; non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease; Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate; metastatic renal cell carcinoma, in combination with interferon alfa; cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

Related: Breast cancer biosimilar shows equivalency to brand

FDA’s approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin.

Mvasi has been approved as a biosimilar, not as an interchangeable product, FDA noted.

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). 

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