Celltrion’s Herceptin Biosimilar Submitted For Approval in Europe

AbbVie v. Amgen (adalimumab)

According to The Korea Herald, the South Korean biopharma company Celltrion submitted their Herceptin biosimilar, Herzuma, to the European Medicine Agency for approval. Herzuma, a biosimilar to Roche’s breast cancer drug Herceptin (trastuzumab), was approved in Korea two years ago for the treatment of metastatic breast cancer, early stage breast cancer and metastatic stomach cancer.

Celltrion also completed their Phase I clinical trials for Herzuma in the US in early September and say they plan to seek regulatory approval from the FDA.

Stay tuned to Big Molecule Watch for updates.

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