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.

The US firm’s high-dose reformulation of Eylea reduced dosing burden for patients with DME and wet AMD in two pivotal studies and could match Roche’s rival drug.

European Medicines Agency insisted on a stricter statistical analysis than the US FDA for demonstrating equivalence on the primary endpoint for both Coherus/BioEq’s Cimerli and Samsung Bioepis’ Byooviz; there also were differences in the regulators' preferred primary analysis population and primary endpoint interval.

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.