C$10mn offered for Apotex Sherman lead

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.

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.