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Celltrion's Herceptin biosimilar seals EU approval

Published on 15/02/18 at 11:12am

Herzuma, Celltrion’s biosimilar version of Roche/Genentech’s blockbuster immunotherapy Herceptin, has been awarded approval from the European Commission, the company has revealed.

The drug has been authorised in all of its reference product’s approved indications, which includes early breast cancer, metastatic breast cancer, or metastatic gastric cancer in patients whose tumours have either HER2 overexpression or HER2 gene amplification.

The decision marks the third approval for a Celltrion biosimilar by the European Commission, and follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) at the end of last year. The drug is currently awaiting a regulatory decision in the US.

“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. 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.”

Matt Fellows

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