- Business Wire
Celltrion, Inc. (KRX:068270) announced today that the European Commission (EC) approved HerzumaÂ® (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 decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 14, 2017.
âThe development of biosimilar is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal against a variety of diseases and to increase patientsâ accessibility to innovative drugs at a more affordable price,â said Woosung Kee, Chief Executive Officer of Celltrion. âWe have already seen many benefits of biosimilars in Europe from our experience with RemsimaÂ® and TruximaÂ®1. Our experience has shown that biosimilars not only reduce individual patientâs out-of-pocket medical expenses but also contribute to lowering financial burden on insurance payers and national health agencies.â
The European Commissionâs approval of HerzumaÂ® marks an important milestone for Celltrion, providing more treatment options for patients. HerzumaÂ® is the third biosimilar from Celltrionâs portfolio approved by the EC.
This decision by the European Commission means that HerzumaÂ® is now approved for marketing in the 28 member states of the European Union (EU), in addition to Norway, Liechtenstein and Iceland.
HerzumaÂ® is an anticancer monoclonal antibody (mAb) biosimilar drug used to treat breast cancer and gastric cancer. Similarity of HerzumaÂ® to the reference product, HerceptinÂ®2, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. In 2017, Celltrion launched HerzumaÂ® in Korea.
About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and ECâs approval for InflectraÂ® and RemsimaÂ®, respectively, which is the worldâs first mAb biosimilar to receive approval from a regulatory agency in a developed country. Celltrion also received ECâs approval for TruximaÂ® (CT-P10, a mAb biosimilar to MabTheraÂ®3 (rituximab)) in February 2017. For more information, visit www.celltrion.com.
1 Celltrionâs mAb products RemsimaÂ® (infliximab biosimilar) and TruximaÂ® (rituximab biosimilar) were approved by the EC in September 2013 and February 2017, respectively.
2 HerceptinÂ® is a registered trademark of Genentech, Inc.
3 MabTheraÂ® is a registered trademark of F. Hoffmann-La Roche AG.