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.
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Coherus has revealed further details of the firm’s plans for its Cimerli interchangeable biosimilar rival to Lucentis in the US, including a launch date and pricing information.
Coherus BioSciences had much to say during its second-quarter earnings call in the wake of USFDA approval for its Bioeq-partnered Cimerli biosimilar to Roche’s Lucentis.
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.