Just a couple of weeks after the US Food and Drug Administration approved Sandoz’s Enzeevu (aflibercept-abzv) biosimilar rival to Regeneron’s top-selling Eylea ophthalmology brand, the originator has slapped Sandoz with a lawsuit alleging that the firm failed to comply with the “patent dance” information-exchange requirements of the US Biologics Price Competition and Innovation Act – to the extent that Regeneron was only able to confirm Sandoz’s aflibercept filing on the day the firm announced FDA approval.
Sandoz disclosed FDA approval for Enzeevu on 12 August (see sidebar), suggesting that the product was set to be “a key biosimilar growth driver in US
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