Biosimilar Launch Notification Delay Remains, Might Not Matter For Newer Products

This article was originally published in The Pink Sheet Daily

05 Jul 2016
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Executive Summary

In Amgen v Apotex, Federal Circuit says biosimilar applicants still need to wait for FDA approval to give reference product manufacturer launch notification regardless of patent dance status, but court suggests notice could be given upon tentative approval.

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Biosimilar Launch Notification Delay Remains, Might Not Matter For Newer Products

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Biosimilar Tentative Approvals Could Flow From US Supreme Court Case

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