FDA committee recommends approval of Mylan and Biocon's proposed biosimilar trastuzumab

Vote marks first proposed biosimilar trastuzumab to be recommended by the committee.

Mylan President Rajiv Malik commented: "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. As one of the largest suppliers of cancer medicines by volume in the US, Mylan is committed to serving this important patient community. 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."

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 US. We now look forward to engaging with the FDA to seek final approval 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.

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