The US Food and Drug Administration on 2 August approved Coherus BioSciences’ Cimerli (ranibizumab-eqrn) as the first interchangeable biosimilar to Genentech’s age-related macular degeneration treatment Lucentis, without the need for a “switching” study.
Cimerli Interchangeable Biosimilar Approved Without Switching Data
Coherus Ranibizumab Rival Will Compete With Lucentis And Byooviz In US
Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.
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