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Explore our thought leadership article library, where you can find a wealth of insights on regulatory intelligence, industry updates, and the latest pharmaceutical and biotechnology developments.
Regulatory Intelligence - 2025 Round Up
An overview of the key regulatory intelligence updates from FDA & EMA released in 2025.
FDA publishes revised Biosimilarity recommendations, offering pathway to more efficient biosimilar approvals
FDA’s draft guidance streamlines biosimilar approval by reducing the need for comparative efficacy studies (CES). The guidance provides revised criteria outlining the circumstances in which conducting CES may be unnecessary for a Biologics License Application submitted through the 351(k) biosimilar and interchangeable biosimilar pathway.