Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
Why this guidance matters In the evolving world of biologics and biosimilars, precise head-to-head clinical trials are expensive, lengthy and sometimes redundant. The FDA recognises this, and in this draft guidance it offers a refined framework to decide when a Comparative Efficacy Study (CES) is really needed — and when it may be safely omitted. […]
Accelerating Biosimilar Development: A Key Move by the FDA
On October 29, 2025, the FDA announced that it is taking major steps to make it faster and less costly to develop biosimilar medicines—the lower-cost alternatives to biologic drugs that treat many serious and chronic diseases. U.S. Food and Drug Administration+2U.S. Food and Drug Administration+2 Specifically, the agency released a draft guidance titled “Scientific Considerations […]
FDA & CDC Recommend Pause of IXCHIQ (Chikungunya Vaccine, Live) for Adults 60+ — An Investigative Update
Published: May 12, 2025 (FDA safety communication).Quick summary: The FDA and CDC have recommended a temporary pause in the use of IXCHIQ® (Chikungunya Vaccine, Live) for people 60 years and older while agencies investigate postmarketing reports of serious neurologic and cardiac events, including deaths. This article explains what’s known, what the agencies are doing, who’s […]
FDA lifts pause on IXCHIQ for adults ≥60 and approves new label warnings
What happened—quick timeline Why the concern in the first place? IXCHIQ is a live, attenuated chikungunya vaccine; it can produce chikungunya-like symptoms. FDA’s case review included serious adverse events in older adults, some consistent with severe complications of chikungunya disease (e.g., encephalitis). One death from encephalitis was specifically noted in FDA’s safety communication, and earlier […]