Celltrion Receives EU Approval for Trastuzumab Biosimilar

INCHEON, South Korea--(BUSINESS WIRE)-- Celltrion, Inc. (KRX:068270) announced today that the European Commission (EC) 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 decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 14, 2017.

“The 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 patients’ accessibility to innovative drugs at a more affordable price,” said Woosung Kee, Chief Executive Officer of Celltrion. “We have already seen many benefits of biosimilars in Europe from our experience with Remsima® and Truxima®¹. Our experience has shown that biosimilars not only reduce individual patient’s out-of-pocket medical expenses but also contribute to lowering financial burden on insurance payers and national health agencies.”

The European Commission’s approval of Herzuma® marks an important milestone for Celltrion, providing more treatment options for patients. Herzuma® is the third biosimilar from Celltrion’s portfolio approved by the EC.

This decision by the European Commission means that Herzuma® is now approved for marketing in the 28 member states of the European Union (EU), in addition to Norway, Liechtenstein and Iceland.

About Herzuma®

Herzuma® is an anticancer monoclonal antibody (mAb) biosimilar drug used to treat breast cancer and gastric cancer. Similarity of Herzuma® to the reference product, Herceptin®², was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. In 2017, Celltrion launched Herzuma® 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 EC’s approval for Inflectra® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. Celltrion also received EC’s approval for Truxima® (CT-P10, a mAb biosimilar to MabThera®³ (rituximab)) in February 2017. For more information, visit www.celltrion.com.

¹ Celltrion’s mAb products Remsima® (infliximab biosimilar) and Truxima® (rituximab biosimilar) were approved by the EC in September 2013 and February 2017, respectively.

² Herceptin® is a registered trademark of Genentech, Inc.

³ MabThera® is a registered trademark of F. Hoffmann-La Roche AG.

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