RegeneRx Biopharmaceuticals, Inc.
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Latest From RegeneRx Biopharmaceuticals, Inc.
Keeping Track: After COVID Delays, US FDA Approvals At Last For Daxxify, Rolvedon (But A CRL For Alvotech)
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
European Medicines Agency insisted on a stricter statistical analysis than the US FDA for demonstrating equivalence on the primary endpoint for both Coherus/BioEq’s Cimerli and Samsung Bioepis’ Byooviz; there also were differences in the regulators' preferred primary analysis population and primary endpoint interval.
Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis
Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.
A timeline of the development and approval of Coherus’ Cimerli, the first interchangeable biosimilar to Genentech’s macular degeneration drug Lucentis, and a listing of FDA staff involved in the review.
- Large Molecule