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Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis

 
• By Sue Sutter

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.

Lucentis Biosimilar Drug review profile
Cimerli was not subject to a 'switching' study prior to earning an interchangeability nod. • Source: Shutterstock

Coherus BioSciences, Inc. and partner Bioeq IP AG provided “sufficient justification” that Cimerli (ranibizumab-eqrn), a biosimilar of Genentech, Inc.’s macular degeneration treatment Lucentis (ranibizumab), will produce the same clinical result in any given patient for each condition of use, the US Food and Drug Administration said in deciding to award an interchangeability designation in the absence of a “switching” study.

This scientific justification took into account information on mechanism of action, pharmacokinetics, immunogenicity and toxicity, the FDA said in a multidisciplinary review memo.

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