Dean has built up a wealth of knowledge on the global generics and biosimilar medicines industries in his five years with Generics bulletin. 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
Dr Reddy’s Laboratories has become the third Revlimid ANDA sponsor to settle patent litigation action with Bristol Myers Squibb’s Celgene. However, the Indian company will join Alvogen in not being able to launch before first settler Natco, which has partnered with Teva’s Watson.
With a federal district court decision opening the door for a multitude of generic Tecfidera products, the market has reacted, suggesting as many as five ANDA products are primed for launch.
In infringement proceedings involving Biogen’s key Tecfidera patent expiring in February 2028, a district court in Delaware has decided that a recent West Virginia invalidity ruling applies under collateral estoppel. The decision means a host of ANDA sponsors could now press on with an “at-risk” launch, like Mylan – the recipient of the invalidity decision – did last month.
Shortly after agreeing to divest three mature Upjohn brands in Australia, Mylan and the Pfizer off-patent and mature brands unit have stepped closer to merging into Viatris, bagging another key regulatory approval that had been in the works for several months.
Fresh from announcing the €642m ($762m) divestment of its Thrombosis business in Europe to Mylan, Aspen Pharmacare management walked investors through its full-year earnings, explaining in detail the company’s ambitions to focus on emerging markets.
Amgen has reiterated the strength and capabilities of its dual commercial model by suggesting it will replicate its strategy for oncology biosimilars for its burgeoning inflammation product portfolio.