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Latest From C.R. Bard
'Incorrect' To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA
US FDA India country director Dr Sarah McMullen provides a fact check at a recent conclave to dispel the notion that interchangeable biosimilars are safer and more effective than other approved biosimilars.
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.
Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements
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.
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- Medical Devices
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