FDA Approves First Oncology Biosimilar

The US Food and Drug Administration (FDA) has approved the first biosimilar for the treatment of various cancers.

Myasi Bevacizumab-awwb (bevacizumab-awwb, Amgen) is the equivalent of Avastin bevacizumab (bevacizumab, Genentech/Roche), which was first approved in the US in 2004 for multiple solid-tumor cancers. The new biosimilar is indicated for metastatic colorectal cancer in combination with intravenous 5-fluorouracil-based chemotherapy or fluoropyrimidine-irinotecan-based chemotherapy, non-squamous non-small cell carcinoma, glioblastoma, metastatic renal cell carcinoma, and cervical cancer.

The FDA’s approval of Myasi came following a 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.
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The adverse effect profile in clinical tests was shown to be similar to the original drug’s. Myasi will carry the same boxed warning for gastrointestinal perforations, would healing complications, and severe or fatal hemorrhaging.

The FDA has emphasized that Myasi has been approved as a biosimilar, not as an interchangeable product.—Zachary Bessette