Following Amgen’s debut of the first US Humira rival earlier this year, as many as eight further FDA-approved adalimumab biosimilars are about to launch. Generics Bulletin breaks down all the different players and how they are positioning themselves in such a competitive market.
Anyone with even a passing interest in the global off-patent industry will likely be aware of the significance of 2023 for the US biosimilars market.
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Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.
Spanish competition regulator the CNMC has announced an investigation into Sandoz and its Bexal subsidiary – as well as Alliance Healthcare España and Bluetab Solutions – over sharing sensitive commercial information relating to pharmacy orders for generics.
Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.
Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.
