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Days After US Aflibercept Approval, Sandoz Is Hit By Regeneron Lawsuit

Originator Alleges BPCIA Patent Dance Failings Over Filing For Proposed Eylea Biosimilar

 
• By Dave Wallace

Days after Sandoz received US FDA approval for its Enzeevu aflibercept biosimilar rival to Regeneron’s Eylea, the originator has hit the firm with a lawsuit alleging that it failed to follow the “patent dance” set out in the BPCIA biosimilars framework and claiming infringement of multiple patents.

Eye with reflection of word "legal"
Regeneron says Sandoz has not followed the BPCIA’s “patent dance” • Source: Shutterstock

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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