Generium is claiming the launch of the world’s first biosimilar version of Roche’s Pulmozyme after receiving approval for dornase alfa in Russia.
Russia’s Generium has claimed a world first with the approval and launch of a biosimilar version of dornase alfa inhalation solution in its home market.
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Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."
After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.
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.
Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.
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.
