Sandoz Steers Enbrel Biosimilar Away From Equivalence Quandary With Reanalysis
Executive Summary
FDA says Sandoz's biosimilar is highly similar to Amgen's Enbrel after Sandoz answered question about data comparing it to US-approved product.
You may also be interested in...
Biosimilars Statistical Guidance Reflects Early Development Approach
US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.
Biosimilars Statistical Guidance Reflects Early Development Approach
US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.
Sandoz’s Erelzi: Biosimilar Pediatric Labeling Strayed From Enbrel
Drug Review Profile of TNF-inhibitor etanercept-szzs examines how US FDA navigated its way around ‘inaccurate’ pediatric psoriasis labeling for the reference product, Amgen’s Enbrel, to reflect current state of the knowledge on the biosimilar’s labeling, albeit only temporarily.