Generic Drugs

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Wockhardt is exiting the US generics market through voluntary liquidation of its loss-making US subsidiaries to double down on innovation and focus on antibiotics and biosimilar insulins.

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

Novartis has filed an immediate appeal after a US district court ruled that MSN Labs would not infringe one of its key patents shielding its $7.8bn Entresto brand, and denied the originator injunctive relief.

Multiple strengths of sitagliptin saw average price increases that topped our rundown of UK generic pricing data in June.

Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.

Just days after Viatris was frustrated in its attempts to challenge IP protecting Janssen’s Invega Trinza, the US Federal Circuit has rejected the firm’s and Teva’s bid to invalidate a patent shielding the one-month version of the brand, Invega Sustenna.

Pro-innovator voices argued that the number of patents asserted in the pharma industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

Sagent and Qilu will look to enhance access, reduce treatment costs, and strengthen supply chains after striking an alliance for a portfolio of the Chinese firm’s complex injectables.

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.