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Regulatory Oversight › FDA Approval › Generic Drugs

Venable LLP

May 2025 Stelara® and Humira® Interchangeable Biosimilar Approvals

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In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more

Hogan Lovells

New drug marketing applications: how do EMA and FDA compare?

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A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

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Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Hogan Lovells

FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)

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The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in...more

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