August 21, 2019

Impact: High

Amgen announced that the U.S. District court of New Jersey ruled in favor of Amgen regarding the validity of two patents protecting exclusivity of Enbrel from biosimilars. 

Sandoz immediately announced that it would appeal the ruling.

inThought Analysis

This appears as another loss for the biosimilar landscape in the U.S. Sandoz and Samsung Bioepis both have etanercept biosimilars approved by the FDA, and Coherus is looking to join that group in the next couple of years. 

The two patents in question expire in 2028 and 2029, which would give Amgen almost a full decade longer of exclusivity in the U.S. With Enbrel’s multi-billion dollar revenue beginning to wane, it would make sense for Sandoz and Samsung Bioepis to reach a settlement with Amgen that would allow for commercialization of their products sooner rather than later, similar to what has been done with adalimumab biosimilars.

Source: Amgen Press Release, Sandoz Press Release

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