FDA approves Samsung/Merck & Co’s Herceptin biosimilar

The FDA has approved a new biosimilar of Roche’s breast cancer drug Herceptin, from Samsung Bioepis and Merck & Co, ahead of the original drug’s US patent expiry in June. Developed by Samsung Bioepis, the FDA has approved the biosimilar, Ontruzant, ruling that the near-copy has no significant differences compared with the original drug in terms of safety and efficacy. Under a deal between the two companies, Merck & Co will market and distribute the drug in the US. The FDA granted approval across all eligible indications – adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. This is Samsung Bioepis’ first oncology biosimilar to receive FDA approval, after Celltrion and Teva got FDA approval for their Herceptin biosimilar, Herzuma, last month.
Mylan has also got its Herceptin biosimilar approved by the FDA, although the launch date is unknown as it has signed a deal with Roche to begin marketing the drug at an unspecified time. At the time the deal was announced in March 2017, Mylan said it expected to be “potentially” the first company to launch a Herceptin biosimilar in the US.