FDA unanimously recommends Mylan and Biocon's Herceptin biosimilar

Mylan and Biocon have revealed that their biosimilar version of Roche and Genentech’s Herceptin (trastuzumab) has received unanimous recommendation from the FDA’s Oncology Drugs Advisory Committee (ODAC) for the treatment of breast cancer.

"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," a joint statement read.

The decision was based on a data which illustrated that there were no clinically significant differences between Mylan and Biocon’s drug versus its reference product, meaning the biosimilar was non-inferior in the same indicated areas.  

"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," Mylan President Rajiv Malik commented. "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."

Arun Chandavarkar, CEO and joint Managing Director of Biocon, added: "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 in order to expand access to a high-quality, affordable option for treating HER2-positive breast cancers."

However, despite the good news, Biocon was hit by the news earlier this week that, despite receiving good manufacturing practice compliance certificates from the French National Agency for Medicines and Health Products Safety during an inspection of the Begaluru production facility where its biosimilar is made, 35 deficiencies in the process were identified. This means that, until they are rectified, neither company will receive authorisation to market the product in the EU.

Meanwhile, Mylan and Biocon’s have submitted the drug for regulatory approval in Australia, Canada, Europe and several emerging markets. Mylan holds the commercialisation rights in the US, Canada, Australia, New Zealand, the EU and Japan, while Biocon shares these rights across the remainder of the world.

Matt Fellows