Celltrion's Biosimilar Strategy Includes Simultaneous EMA/FDA Reviews

Herceptin and Rituxan biosimilar applications expected to reach FDA early next year while EMA review is ongoing; timing could be another test for 351(k) pathway in US.

Celltrion Inc. plans to send its two upcoming biosimilar applications to FDA in the next few months while their European approval process is ongoing.

The company told the Pink Sheet that it intends to file for FDA approval of its biosimilars of Biogen...

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