Gedeon Richter and Bio-Thera Solutions have announced a European licensing deal worth potentially more than $100m for the Chinese biosimilar developer’s BAT2206 proposed rival to Stelara.
Delegates from European institutions and industry representatives unpacked the many challenges of improved access to critical medicines on the continent in a session at this year’s European Health Forum.
Days after Gilead’s signing of voluntary licensing with six generic manufacturers for its HIV drug Sunleca, ViiV announced its commitment to ramping up Apretude’s supply to countries in need.
Teva has resolved a pair of civil US Department of Justice lawsuits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act through its alleged conduct conspiring to fix the price of three generic drugs and for allegedly paying Medicare patients’ copays for its multiple sclerosis brand Copaxone.
In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.
Lupin has added two ADHD drugs to its Canadian portfolio, while also signing multiple branded deals in other global markets.
Hyloris recognized that the suspension of its shares as part of a broader business fallout has “created uncertainty and temporarily impacted management and organizational focus,” as it got another commercial deal over the line for its Maxigesic IV (paracetamol/ibuprofen) solution for infusion.
Teva has broken new ground by filing its first independent biosimilar to the US Food and Drug Administration, for a proposed biosimilar to Amgen’s Prolia treatment for osteoporosis in postmenopausal women. However, the Israeli firm made no mention of its proposed Xgeva biosimilar, which it states is in Phase III clinical trials.
Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.
Neuraxpharm is making further waves outside of Europe, launching operations in the Middle East just a year after entering Central and South America.
The world’s best-selling diabetes medicine, with sales last year across the globe of around $14bn, is now in the crosshairs in the US for Viatris’ Mylan and its partner Natco, after the firms announced an agreement settling litigation that was pending before the US Patent and Trademark Office’s Patent Trial and Appeal Board.
Biocon Biologics chief commercial officer for advanced markets Matt Erick says the firm is a “quiet giant” in the biosimilars space, but speaks up about the firm’s plans to grow its business in Europe, explore in-licensing as well as in-house development, and capitalize on the upcoming loss of exclusivity for Stelara in the US.
Aspire Pharma has bolstered its dermatology portfolio by striking a deal to acquire “all assets” of another UK-based player, Canute Pharma.
Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as “not of standard quality”. Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market.
Amneal will lend its expertise in product development and manufacturing under a collaboration with obesity and metabolic disorders start-up Metsera – the latest in a recent string of deals involving the highly sought-after GLP-1 analogs.
Teva is continuing along its well-trodden path of partnered biosimilar assets, striking a further agreement with Spanish develop mAbxience that could be for the development of either pembrolizumab or nivolumab.
Aeon Biopharma has heralded its latest interaction with the US FDA over its planned Botox biosimilar as a win that sets the stage for analytical studies, trials and a subsequent filing.
Teva has begun shipping the first US generic version of Novartis’ Sandostatin LAR Depot – a synthetic polypeptide that is part of a difficult-to-manufacture class of long-acting polymers.
Teva’s CEO Richard Francis has spoken candidly about the steps he has taken in order for Teva to reclaim its credibility, underpinned by the company’s ‘Pivot to Growth’ strategy.
Organon and Henlius have marked progress on their partnered HLX11 pertuzumab candidate, with the proposed biosimilar to Perjeta meeting the primary endpoint in a Phase III trial.