Biosimilars

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

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.

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.

South Korea’s Celltrion has doubled down on its efforts in further building its pipeline, eyeing a target of 22 commercialized products by 2030 while also aiming to submit INDs for 13 novel compounds.

Samsung Bioepis and Teva have provided clarity on the pricing of their Epysqli biosimilar to Soliris in the US, as the firms launched only the second rival to the rare diseases treatment.

The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.

Teva is charting a new course under its ‘Pivot to Growth’ strategy, providing a memory aid for investors to better understand the firm’s financials going into 2025.