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Interchangeable Biosimilar Approved Without Switching Data; Cimerli To Compete With Lucentis

Executive Summary

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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