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
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.
Principal deputy director of the US FDA’s Center for Drug Evaluation and Research, Jacqueline Corrigan-Curay, used part of her 20-minute keynote address at the recent AAM Access! annual conference to focus on drug shortages that persist across the US.
An antitrust lawsuit accusing Pfizer of conspiring to delay generic competition to its Lipitor blockbuster came soon after generics entered the US market in November 2011. Only now, after a decade of back and forth, has a deal been agreed to dismiss the accusations.
Alvotech has ensured there won’t be any legal hurdles to overcome as it plots launches via commercialization partners for its AVT04 proposed biosimilar to Stelara in major global markets.