Mylan and Biocon’s Biosimilar to Herceptin Demonstrates Comparable Efficacy

During a presentation at the 2016 American Society of Clinical Oncology (ASCO) in Chicago on June 3, 2016, Mylan announced that MYL-1401O, its biosimilar to Roche’s Herceptin (trastuzumab), demonstrated comparable efficacy in Phase III clinical trials for the treatment of HER2-positive breast cancer. The molecule is being developed in collaboration with India’s Biocon Ltd. The biosimilar to Herceptin is one of the six biosimilar programs on which Mylan and Biocon will collaborate.

At 24 weeks, the response rates with MYL-1401O combined with taxane chemotherapy vs. Herceptin with taxane chemotherapy were 69.4% and 64%, respectively. Serious adverse events were 38% with MYL-1401O and 36% with Herceptin, demonstrating comparable safety profiles. The abstract presenting the results of this HERITAGE trial was selected for the “Best of ASCO” program in 2016, according to a Mylan press release. Mylan President Rajiv Malik commented in the release, “As one of the first companies in the industry to successfully complete a confirmatory efficacy and safety study comparing a proposed biosimilar to a branded cancer drug, this is a significant milestone for Mylan’s biosimilar program.”

Total sales in Roche’s pharmaceuticals division were up 5% in 2015, and these increases were driven by oncology medicines Herceptin, Avastin (bevacizumab), and Perjeta (pertuzumab)‎, as well as Esbriet (pirfenidone)‎ for idiopathic pulmonary fibrosis. Sales for Herceptin alone increased 10% in 2015 and accounted for 17% of pharmaceutical sales in 2015. It was the second-largest seller for Roche in 2015, closely following sales for Avastin, which dominated 18% of Roche's sales in 2015.

Other companies, including Pfizer and Amgen, are also developing biosimilar versions to Herceptin (PF-05280014 and ABP 980, respectively). Although the patent expiration date in the United States for Herceptin is supposedly set for 2019, innovator companies are putting their resources into fortifying their patents to defend branded medications against biosimilar competition and are stressing in company press releases that biosimilars are not exact copies.