The US Food and Drug Administration has given the green light for biosimilar competition to the near $6bn eye-disease juggernaut Eylea, but a major legal overhang is currently throttling the potential for any near-term launches. Generics Bulletin explores the lay of the land, including the recent scheduling conference in the now-consolidated trial involving five aflibercept biosimilar sponsors.
When it comes to treating wet age-related macular degeneration, Regeneron/Bayer’s Eylea (aflibercept) 2mg has long been the flagbearer. With annual sales of nearly $6bn in the US alone, biosimilar sponsors have planned for years to take a piece of the pie for themselves while delivering savings for the nation’s healthcare system.
All eyes were on the US Food and Drug Administration as the brand’s US regulatory exclusivity drew to a close...
Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.
The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.
A class action suit alleging AstraZeneca delayed generic competition for Seroquel XR by making illegal agreements that stifled market entry for generic quetiapine competitors has been dismissed after the originator agreed to settle for tens of millions of dollars.
In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.
Generics Bulletin reviews global regulatory developments across the world.
Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
