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.

Eye data binary
Cimerli was not subject to a 'switching' study prior to earning an interchangeability nod • Source: Shutterstock

More from Biosimilars

More from Products