Generics
As the generic drug industry warily watches another transition process for propellants in metered-dose inhalers, the US FDA is urging companies not to discontinue development because they are afraid of being caught in the switch.
In the aftermath of last week’s J.P. Morgan Healthcare Conference in San Francisco, Generics Bulletin’s editorial team brings you additional coverage of items of interest for the global generics and biosimilars industry.
Recently-appointed president of Medicines for Europe Stephan Eder speaks to Generics Bulletin about the off-patent association’s priorities to secure a sustainable operating environment for the generics, biosimilars and value-added medicines sector in Europe.
ANI Pharmaceuticals will compete with a product bringing in annual sales of more than $150m after launching the first generic with 180-day exclusivity via the FDA’s competitive generic therapy pathway.
The FDA delivered its “Christmas gift” of approving Hikma’s generic Victoza, the first once-daily liraglutide injectable on the US market.
The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.
Adalvo and CNX Therapeutics have together claimed the first UK launch of a nitrofurantoin generic, introducing their prolonged-release formulation and revealing plans for further European launches.
Sandoz has announced a $275m settlement to resolve with end payers class action antitrust litigation in the US over historical price-fixing allegations, as well as disclosing that it has made a further provision of $265m linked to the case.
Sawai has teed up multiple new launches in Japan after reporting the listing of five generics across ten presentations in the country’s National Health Insurance drug price list. The new registrations come after the firm reported lukewarm first-half results amid ongoing domestic supply issues.
Indian player Indoco has struck a deal with UK distributor Clarity Pharma that will allow it to target the UK market with the launch of 20 products over the next 18 months.
Lupin is looking to be ready on day one to challenge Merck & Co’s Janumet (metformin/sitagliptin) treatment for type 2 diabetes, after the US Food and Drug Administration tentatively waved through its ANDA product.
Viatris is shedding another of its off-patent interests, striking a deal for Safecor Health to acquire its US unit-dose packaging business.
The latest update on product-specific guidances for generic development from the FDA included 60 new and newly-revised PSGs as well as an update on future guidances coming down the line in the next year.
The BGMA has lauded as “comprehensive and welcome” a report published by the Royal Pharmaceutical Society on UK shortages, just weeks after the BGMA put forward its own supply-chain policy proposals.
Mallinckrodt has spoken about maintaining a steady organization, underpinned by few launches in the pain and neurodevelopmental disorders space.
The first GLP-1 agonist to receive US Food and Drug Administration approval, Byetta (exenatide), has generic competition at last, with Amneal bagging the first rival after Teva seemingly abandoned its proposed generic version.
With a first wave of generic weight-loss medicines poised to hit the UK, local off-patent industry association the BGMA says market dynamics could be unlike those of a typical generic or biosimilar launch, with the current level of unmet demand unclear.
MSN Laboratories has struck a patent-litigation settlement deal with BeiGene that will allow it to launch its zanubrutinib generic rival to Brukinsa in the US from 2037.
The US Supreme Court has failed to come to the aid of Norwich Pharmaceuticals in its legal battle over a generic version of Xifaxan (rifaximin) that has a patented indication carved out of its label. An earlier decision over the generic thus bars approval and launch until 2029.
The UK’s National Health Service is set to roll out Teva’s varenicline smoking-cessation daily tablet to “tens of thousands” of smokers in England.