A few weeks after the US Food and Drug Administration approved Sandoz’s Enzeevu (aflibercept-abzv) biosimilar of Regeneron’s Eylea, the originator sued Sandoz alleging the firm failed to comply with the “patent dance” information-exchange requirements of the US Biologics Price Competition and Innovation Act, arguing that it was only able to confirm Sandoz’s aflibercept filing on the day of its clearance.
Days After US Aflibercept Approval, Sandoz Is Hit By Regeneron Lawsuit
Days after Sandoz received US FDA approval for its Enzeevu aflibercept biosimilar, Regeneron sued alleging that Sandoz failed to follow the “patent dance” set out in the BPCIA framework and claiming infringement of multiple patents on its Eylea.
More from Biosimilars
• By
The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.
• By
Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”
• By
Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.
• By
Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.
More from Biosimilars & Generics
• By
Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.
• By
Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”
• By
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.