Following the drug’s earlier approval as a biosimilar to Prolia, China’s regulators greenlighted the use of Mabwell’s denosumab as a substitute for the second branded version, Xgeva, in its indications.
Mabwell has scored a country-wide first as China’s National Medical Products Administration approved its 120mg biosimilar to Amgen’s Xgeva (denosumab) for use in the nation.
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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.
With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.
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.
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.
