FDA Advisory Committee Recommends Approval of Mylan and Biocon's Proposed Biosimilar Trastuzumab

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India: Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies' proposed biosimilar trastuzumab.

The committee voted 16-0 in support of eligible indications of the reference product, Herceptin®, which include HER2-positive breast cancer in the metastatic and adjuvant settings.

Biocon CEO and Joint Managing Director Dr. Arun Chandavarkar said: "We welcome ODAC's endorsement of our biosimilar trastuzumab as it brings our collaboration a step closer to addressing the critical needs of cancer patients in the U.S. We now look forward to engaging with the FDA to seek final approval in order to expand access to a high-quality, affordable option for treating HER2-positive breast cancers."

Data presented to ODAC included results from analytical, nonclinical and clinical studies which demonstrated that our proposed biosimilar trastuzumab is highly similar to Herceptin, in line with the FDA assessment provided in the pre-meeting briefing documents. ODAC determined that no clinically meaningful differences exist between the biosimilar product 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.

FDA uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals. FDA often follows the advice of ODAC in determining whether a product should come to market, although they are not required to follow it.

Mylan and Biocon's proposed biosimilar trastuzumab also is under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.