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.
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The 180-day notification period has passed for biosimilar of Celltrion's Remicade, but Pfizer seems to be aiming for an at-risk launch sometime this year.
Teva is looking to tap into $6.5bn in US sales of Herceptin and Rituxan in a new deal for North American rights to two of Celltrion's pipeline biosimilars for $160m upfront.
Samsung Bioepis's trastuzumab has become the South Korean company’s fifth biosimilar candidate to be filed for approval in Europe and also marks its planned entry into the oncology sector in the region.