Biosimilar Tentative Approvals Could Flow From US Supreme Court Case
If high court decides that biosimilar sponsors must wait until licensure before providing 180-day notice of commercial launch, FDA may face pressure to start granting tentative licenses for 351(k) applications, industry lawyer says.
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During oral arguments in Sandoz v Amgen, justices suggest FDA issue rule-making on whether biosimilar sponsors can give early notification of launches and need to follow all the steps in the patent dance. The agency has explicitly said it wants to be left out of it.
High court set to determine timing of biosimilar marketing and how parties handle patent disputes in Sandoz v. Amgen. Stakeholders say the outcome will impact innovation, access to biosimilars and future litigation.
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.