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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As part of BsUFA III, the FDA has announced that it will be commencing its regulatory science research program, which will focus on advancing the development of interchangeable products and biosimilars.
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.