Biosimilar Herzuma approved in EU

The European Commission (EC) has approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification.

The positive decision for South Korean firm Celltrion (Kosdaq: 068270) follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 14, 2017. It follows the EC approval of Samsung Bioepis’ trastuzumab biosimilar, Ontruzant, in November last year.

Other biosimilars of Roche’s blockbuster breast and gastric cancer drug Herceptin include the partnership of India’s Biocon (BSE: 532523) and Netherlands-headquartered Mylan (Nasdaq: MYL), with the latter duo one of the leaders in the race for approval in the USA, where the last composition of matter patent for the original will expire in 2019.Herceptin sales in full-year 2017 grew 3% to 7.01 billion Swiss francs ($7.5 billion).