Sandoz Skips Enbrel Biosimilar Patent Dance, Spurs Infringement Suit
This article was originally published in The Pink Sheet Daily
Executive Summary
For second time Sandoz faces claims it is trying to reap benefits of biosimilars law without meeting its obligations.
You may also be interested in...
Erelzi's Disappearing Indications: Biosimilar Loses Two Of Enbrel's Labeling Claims
Sandoz's request that US FDA remove psoriatic arthritis and plaque psoriasis indications from biosimilar's approved labeling appears aimed at defending against patent infringement claims brought by Amgen, legal experts say.
Erelzi's Disappearing Indications: Biosimilar Loses Two Of Enbrel's Labeling Claims
Sandoz's request that US FDA remove psoriatic arthritis and plaque psoriasis indications from biosimilar's approved labeling appears aimed at defending against patent infringement claims brought by Amgen, legal experts say.
Biosimilar Legal Landscape: Lessons From 2017
In several firsts last year, US Supreme Court ruled on BPCIA, Amgen won a damages award in infringement litigation, and Amgen and Mylan inked deals clearing way for future launch of Humira and Herceptin biosimilars. Chart includes status of 15 cases and questions teed up for courts to tackle in 2018.