FDA advisory committee backs first trastuzumab biosimilar

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has recommended approval of the first biosimilar version of trastuzumab, a breast cancer-fighting monoclonal antibody.

Filed by Mylan and Biocon, the biosimilar application was approved unanimously by the committee, which provides expert advice to the FDA. However, the agency does not have to follow the committee’s decision.

The reference product for trastuzumab is Herceptin, made by Genentech, and data presented to the committee showed the applied-for drug to be highly similar to the branded version.

According to a statement from Mylan and Biocon (an Indian biopharmaceutical company), the committee said no clinically meaningful differences exist between the biosimilar and Herceptin in terms of safety, purity and potency.

“As such, the committee concluded that the totality of evidence supports a recommendation for FDA approval,” they added.

According to Genentech, Herceptin is approved to treat early-stage breast cancer that is human epidermal growth factor receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2+ and has not spread into the lymph nodes.

Mylan president Rajiv Malik said the company looks forward to working with the FDA to further increase access to this “important treatment option for the thousands of patients affected by HER2-positive breast cancer each year”.

The companies’ proposed biosimilar trastuzumab, which is also being reviewed by regulatory authorities in Australia, Canada, Europe and other jurisdictions, is one of six biologic products that Mylan and Biocon are co-developing.

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