Celltrion Wins Korea Approval For Roche Herceptin Biosimilar

Celltrion gains approval for its second monoclonal antibody biosimilar following a biosimilar of Johnson & Johnson’s Remicade. The approval marks the second entry of a Herceptin biosimilar and the first based on global clinical trials, but Roche believes it is adequately protected against the competition.

SEOUL – South Korea’s biosimilar frontrunner Celltrion Inc. received approval from the Ministry of Food and Drug Safety for sales in Korea of Herzuma (trastuzumab), a biosimilar of Roche’s blockbuster Herceptin (trastuzumab). MFDS approved the compound for early and advanced HER2-positive breast cancer and for advanced stomach cancer.

The product is Celltrion’s second approved monoclonal antibody biosimilar following Remsima, a biosimilar of Johnson & Johnson’s tumor necrosis...

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