FDA Recommends Approval of Trastuzumab Biosimilar

Mylan and partner Biocon receive a unanimous recommendation for approval of their biosimilar treatment for breast cancer.

A US FDA advisory committee has unanimously recommended the approval of another biosimilar. In this case, the positive recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC) is for Mylan and Biocon’s biosimilar of Herceptin (trastuzumab), a breast cancer treatment originally developed by Roche.

The unanimous (16-0) decision was based on results of analytical, nonclinical and clinical studies demonstrating the similarity between the proposed biosimilar and the reference drug, according to Mylan. “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,” as stated in a company press release.

The partnership between Mylan and Biocon covers the co-development of six biologic drugs and includes the proposed biosimilar trastuzumab. Mylan has exclusive rights for the commercialization of trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive rights with Mylan to commercialize the biosimilar in the rest of the world. The two companies have also filed for approval of their proposed biosimilar trastuzumab in Australia, Canada, Europe and several emerging markets. 

"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,” said Mylan President Rajiv Malik. “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."

Commented Dr. Arun Chandavarkar,, CEO and Joint Managing Director of Biocon: "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."


Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.