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
With Eagle set to launch its long-awaited vasopressin ANDA product on 17 January, the US firm’s management told investors it was unsure what its launch meant for the 505(b)(2) rival product in the hands of American Regent.
Glenmark is celebrating a “major milestone,” after its Ryaltris nasal spray to treat seasonal allergic rhinitis was approved by the FDA. Hikma will handle commercialization in the US, as part of its continued specialty push in the market.
Teva CEO Kåre Schultz has weighed in on Novartis’ plans to conduct a strategic review for its Sandoz unit, while also airing frustrations over continued delays for complex products in the US.
AbbVie is not yet changing its modelling for Humira’s erosion in 2023, when as many as nine competing biosimilars could launch. The originator stated however that it will be in a better position to comment when it “goes through negotiations this summer” with payers and insurance providers.
A delay in FDA approval for partner Alvotech’s proposed high-concentration biosimilar version of Humira has not concerned Teva, especially after the product was approved by the EMA at the end of last year. There “shouldn’t really be any challenges here,” management says.
ANI is now firmly in the clear for its $210m acquisition of Novitium, following FTC approval of an order requiring divestiture of rights and assets to two generic products. The US-based firm is on an upward trajectory following its recent approval for Cortrophin Gel.