Regulatory Guidance

Amgen wins Enbrel patent protections — for now

Aug 12, 2019

Amgen has fought off a patent challenge from Novartis to its blockbuster anti-inflammatory, Enbrel.

A U.S. District judge heard arguments from Novartis’ Sandoz unit, which is looking to launch a biosimilar of Enbrel, that the patents on the drug’s active ingredient should not be upheld because they contain concepts from other patents. But the judge disagreed, and rendered a verdict that could protect Enbrel from biosimilar competition until 2029.

The decision was a blow to Novartis, whose Enbrel biosimilar, Erelzi won FDA approval in 2016. The company had hoped to roll out Erelzi on the U.S. market next year.

Enbrel was first released in the U.S. in 1998 and pulled in $4.8 billion in sales last year. 

Novartis is expected to appeal the judge’s decision.

Read the Reuters report.

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