Following its recent presentation of results for the third quarter of the 2024 fiscal year, Organon’s US biosimilars lead Jon Martin spoke to Generics Bulletin about the company’s adalimumab plans and strategy with upcoming launches, as well as how these will benefit from the firm’s focus on women’s health.
A few months after a positive Phase III trial readout, Henlius has filed an application for its Organon-partnered Perjeta biosimilar in its domestic Chinese market.
Generics Bulletin reviews the latest developments in the regulatory arena across the globe.
An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.
The US PTO is facing criticism after withdrawing a proposed rule that sought to address double-patenting with changes to terminal disclaimers.
Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs.
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.
Medicines for Ireland had its demands for the off-patent sector heard by some political parties, which are pledging to improve access to generic and biosimilar drugs ahead of the election.
Rosemont Pharmaceuticals will commercialize Hyloris’ proprietary valacyclovir oral suspension in the US under a new partnership that has been agreed between the two firms.
Europe risks “missing out on a massive opportunity” if it does not improve its efforts to recognize and take advantage of the benefits of value added medicines, according to Medicines for Europe sector chair and Pharmanovia CEO James Burt.
Buoyed by the success of its long-acting risperidone injectable, Teva is continuing to feel upbeat about the potential for its olanzapine LAI candidate, ahead of a full study safety readout anticipated in the first half of 2025.
Hyloris recognized that the suspension of its shares as part of a broader business fallout has “created uncertainty and temporarily impacted management and organizational focus,” as it got another commercial deal over the line for its Maxigesic IV (paracetamol/ibuprofen) solution for infusion.
Fresenius Kabi was unable to persuade a US court that its proposed generic version of Heron Therapeutics’ Cinvanti (aprepitant) injectable emulsion for chemotherapy-induced nausea and vomiting would not infringe a pair of patents stretching into the next decade.
Will Novartis’ monopoly on Entresto, one of the biggest-selling small molecule drugs in the US, last until its proffered mid-2025 date? An unfavorable decision by the US Court of Appeals for the Federal Circuit that has handed victory to ANDA sponsor MSN Labs could upend the originator’s projection.
The wait for US competition to AbbVie’s Lumigan 0.01% glaucoma brand, launched more than a decade ago, goes on, after Mankind bowed to infringement of a key US patent.
A watershed moment is on the horizon for US biosimilars, with Amgen looking poised to debut competition to Eylea (aflibercept).
