Intellectual Property

Dr Reddy's had not ruled out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Dr. Reddy's doesn’t fully rule out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Beximco said it will manufacture a generic rival to Vertex’s Trikafta, offering cystic fibrosis patients a much-needed cheaper alternative. However, people will be subject to domestic personal use importation laws to access the drug.

Roche, which faced a high stakes patent setback for Evrysdi in India, appears to have appealed against a lower court’s ruling, which went decisively Natco’s way but also included distinct 'reservations' by the judges.

Thanks to settlements with three generic challengers – Cipla, Laurus Labs and Lupin – Gilead says it has now kept competition to its $13bn Biktarvy brand off the US market until April 2036.

Under a pair of deals arranged through Unitaid, the Clinton Health Access Initiative and Wits RHI, as well as the Gates Foundation, Dr Reddy’s and Hetero will be able to sell low-cost generic versions of Gilead’s injectable lenacapavir HIV prevention treatment in LMICs.

Ireland, which according to industry experts has an “outsized” voice in representing the pharmaceutical sector, is set to take over the presidency of the Council of the European Union next summer.

Two bills, both streamlining the regulatory pathways for generics and biosimilars, are once again presented and debated at the US House of Representatives.

India revokes Novartis's patent pertaining to Entresto, upholding the objections of opponents including the Indian Pharmaceutical Alliance on lack of novelty and prior claiming, among others. Novartis decided against participating in the hearings.

In the second part of Generics Bulletin’s interview with Róbert Wessman, the Alvotech founder, chairman and CEO discusses global moves towards biosimilar streamlining – as well as talking PBMs, price negotiation, US trade tariffs and the push towards reshoring manufacturing.

In a newly published report, the US Association for Accessible Medicines highlights the urgent need for legislative reform to deter originators from continuously asserting and litigating patents.

Reflecting significant upcoming opportunities for the off-patent sector, the World Health Organization has added pembrolizumab – sold as Keytruda – and various GLP-1s to its latest essential medicines list.