Dean has built up a wealth of knowledge on the global generics and biosimilar medicines industries since joining Generics Bulletin in 2013. He specializes in commercial and legal issues, writing in-depth analyses of corporate strategy and getting under the skin of patent infringement proceedings and other litigation. He attends investor and regulatory meetings with business leaders, favoring the investor days with their focus on corporate strategy. In his spare time, Dean enjoys visiting museums and playing five-a-side football.
Latest From Dean Rudge
Generics Bulletin previews the most noteworthy and anticipated events for March 2024.
“Innovating cancer care for patients is a winning strategy,” Coherus said as it delivered on the first US biosimilar version of Amgen’s dominant pegfilgrastim formulation, using an on-body device to deliver the medication, months after a protracted FDA approval.
Hikma welcomed a strong and profitable 2023, driven by the nourishing effects of its authorized generic Xyrem product, which will fall back this year as the rate of royalties owed to the brand’s innovator climbs. But the company is optimistic it can continue growth in 2024, including through its $1.2bn Injectables division, which rushed in to fill supply gaps last year.
Fresenius Kabi insists there is a “business plan behind everything” as it divulged a higher cost savings goal for the end of next year, following a fruitful 2023. But queries over margins led the company to stress that it was combatting a variety of uncertainties, especially in China and for its burgeoning biosimilars unit.
In a much watched and controversial case that may have significant ramifications on the “chilling effects” of generics manufacturers in Israel being deterred from chasing after approvals in which an originator has deceitfully sought to ‘evergreen’ its branded intellectual property, the Israeli Supreme Court has once again come down on the side of the generics industry.
Samsung Bioepis is among a small pool of players heading to the clinic for a proposed biosimilar to Merck & Co’s PD-1 mega-blockbuster, as interest and investment rises ahead of patent expiry at the end of the decade.