Celltrion Receives Positive CHMP Opinion for Herzuma for Trastuzumab Biosimilar

Celltrion, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma® (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) 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 CHMP’s opinion will now be sent to the European Commission (EC) for final review.

Herzuma® is a biosimilar to Herceptin®i, a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin® is a blockbuster drug which had worldwide sales of CHF 6.8 billionii (US$6.8 billion) in 2016, of which CHF 2.1 billioniii (US$2.1 billion) was in European sales.

“We welcome the CHMP’s recommendation. By providing more treatment options, biosimilars open more opportunities for greater affordability and improve access to wider use of biotherapeutics. Herzuma® could become a cost-effective alternative to biologics for treatment of breast cancer and gastric cancer, since biologics, which cost much more than conventional anticancer drugs, place undue financial burden on patients and the general healthcare system.” said Woo Sung Kee, Chief Executive Officer of Celltrion.