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BioPharmaceutical United States Legal Issues

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

This article was originally published in The Pink Sheet Daily

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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