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.
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.