The IGBA’s CEO advisory committee of top off-patent industry leaders has met with Daren Tang, director general of the WIPO, to discuss the importance of a balanced global intellectual property regime.
The CEO advisory committee of the International Generic and Biosimilar Medicines Association has opened up a dialogue with the World Intellectual Property Organization to put forward the off-patent industry’s views on the importance of a balanced global IP regime.
Chaired by Sandoz CEO Richard Saynor, the IGBA committee has met with WIPO director Daren Tang, offering what the IGBA...
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.
