BioPharmaceutical

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.

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

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.

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.

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.

An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.

Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.

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.