On December 16, 2017 Celltrion, Inc. (KOSDAQ: 068270) reported 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 (Press release, Celltrion, DEC 16, 2017, View Source [SID1234522673]). 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 billion[ii] (US$6.8 billion) in 2016, of which CHF 2.1 billion[iii] (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.
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About Herzuma
Herzuma is an anticancer monoclonal antibody (mAb) biosimilar used to treat breast cancer and gastric cancer. Similarity of Herzuma to the reference product, Herceptin, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials covering various indications such as HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer. Celltrion also submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA). In 2017, Celltrion launched Herzuma in Korea.