CER Daily Newsfeed

FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable

(3/9, FDA Press Release) “...Specifically, this draft guidance provides updated recommendations to prospective biosimilar applicants seeking to use data from a comparator product approved outside the U.S. as evidence that a proposed product is biosimilar to the U.S.-licensed product. The recommendations describe scenarios in which a biosimilar applicant may use clinical data from outside the U.S. without additional data from a three-way PK study (using the proposed biosimilar, the U.S.-licensed reference product, and the non-U.S.-licensed comparator product). The revisions also remove the earlier recommendation for at least one clinical PK study that directly compares the proposed biosimilar with the U.S.-licensed reference product to support a demonstration of biosimilarity; instead, a PK study can use a comparator product approved outside the U.S. if scientifically justified.” Full

The Atropos Evidence Agent Will Deliver AI-Powered Evidence within Physician Workflow with Deeper Ambient Collaboration with Microsoft

(3/10, Atropos Health Press Release) “Atropos Health, the pioneer in translating real-world clinical data into personalized real-world evidence (RWE), today announced a collaboration with Microsoft Dragon Copilot, an AI clinical assistant, at Stanford Medicine. This collaboration saves physicians time by providing access to personalized evidence integrated into the electronic health record (EHR) at the point of care. Personalized RWE is generated from Stanford data, including patient information generated by Dragon Copilot.” Full

Verana Health Enhances World Renowned RWD Ophthalmic Registry with Images

(3/10, Verana Health Press Release) “...Verana Health has exclusive access to RWD from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) with longitudinal (12+ years), point-of-care data on over 87 million de-identified patients from over 15,000 contributing clinicians to advance clinical research, treatment optimization, and patient outcomes. Under the Imaging Consortium, Verana Health will have access to new images, by continuing to run the infrastructure and analytics that powers the consortium.” Full