Bengaluru: Biocon Limited has 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.
Mylan President, Mr 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 U.S., 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 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.”
Oncologic Drugs Advisory Committee of the USFDA determined that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency.