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Celltrion Genentech FDA Approval

Venable LLP

Amneal / Kashiv Submit an aBLA for Xolair® (omalizumab) Proposed Biosimilar ADL-018

Venable LLP on

On September 26, 2025, Amneal / Kashiv announced the submission to the FDA of an aBLA for ADL-018, a proposed biosimilar of Genentech’s Xolair® (omalizumab)....more

Goodwin

Year in Review: The Top-Five U.S. Biosimilar Market Developments of 2019

Goodwin on

As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more

Goodwin

Teva and Celltrion Launch Rituximab Biosimilar in US

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On November 7, Teva Pharmaceuticals USA, Inc., and Celltrion, Inc., announced that TRUXIMA® (rituximab-abbs) will be available in the United States beginning November 11. As we previously reported, TRUXIMA® is the first...more

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