Generics
The latest development in the long-running US generic price-fixing saga has seen Sun Pharma agree a $200m settlement in connection with an end purchaser action in Pennsylvania.
There is now just one week left to submit entries to the Global Generics & Biosimilars Awards 2025, with the entry deadline set for August 1.
The Court of Appeal in London has upheld a key UK patent shielding Astellas’ Xtandi, rejecting claims by a trio of generic drugmakers that it was obvious after finding that the generics firms’ expert analysis was tainted by hindsight.
At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.
Novartis has failed to secure a court order to stop MSN from launching a generic Entresto, and has also seen an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.
Generics Bulletin reviews global regulatory developments across the world.
A new life sciences strategy unveiled by the UK government has won plaudits from the off-patent industry for its inclusion of measures specifically geared towards generics and biosimilars – especially a £1bn savings target linked to biosimilar uptake.
Cipla's leadership fields shareholder queries on the specter of US tariffs and also outlines how the firm is nurturing the business for the future in areas like mRNA and point-of-care diagnostics, while building on its strength in the respiratory space.
Private equity firm EQT is taking control of Alvo group B2B business Adalvo, after striking a deal to acquire a majority stake from Aztiq, the investment vehicle of founder Róbert Wessman.
Trump’s FTC has carried on two legacies – trying to eliminate improper drug patent listings and making minimal impact on such efforts.
Amphastar has announced plans to quadruple its domestic production capacity over the next three to five years. The move plays into a growing trend towards US manufacturing localization, against the backdrop of potential pharmaceutical tariffs being mooted by the Trump administration.
As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.
The Medicines Patent Pool’s extended voluntary license to produce long-acting cabotegravir to treat HIV is a win for patients living in LMICs, as the WHO updated its guidance to recommend it as an alternative treatment option.
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.