Biosimilar receives approval recommendation from oncology committee

The US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of the proposed biosimilar trastuzumab for the treatment of breast cancer.

Trastuzumab is a biosimilar being developed through the exclusive partnership of Mylan — a global pharma company — and Biocon — and Indian biopharma company. Data presented to ODAC during the review meeting included results studies demonstrating the similarity of the biosimilar trasuzumab to Herceptin, which is the brand product developed originally by Roche.

Based on the results presented to the committee, it was determined that no clinically meaningful differences exist between the biosimilar and the reference product in terms of safety, purity and potency. Therefore, it was concluded that the evidence supports a recommendation for FDA approval.

“We are pleased with ODAC’s recommendation to support the approval of Mylan’s proposed biosimilar trastuzumab to increase affordability, competition and most importantly overall access and use,” commented Rajiv Malik, president of Mylan. “We look forward to working with FDA to further increase access to this important treatment option for the thousands of patients affected by HER2-positive breast cancer each year.”

This therapy is also under review by regulatory bodies in Australia, Canada, Europe and several emerging markets.