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Apotex's Neulasta, Neupogen Biosimilars Clear Legal Hurdles, But Approval Questions Remain

Executive Summary

Federal appeals court affirms ruling that Apotex's biosimilars do not infringe Amgen's manufacturing process patent, but its applications have stalled at FDA for the past three years.

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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.

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.

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