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
Fresenius Kabi discussed the latest around the potential of an FDA warning letter at its key injectables plant in Melrose Park, after earlier this year confirming that no product launches from the site were anticipated in 2021.
Coherus BioSciences has had its say on the prospect of interchangeability for Humira biosimilars, shortly after Boehringer Ingelheim announced positive data from a ‘first-of-its-kind’ switching study.
Teva said it was once again at the mercy of the COVID-19 pandemic as it forecasted an extended if not indefinite wait for both criminal and civil proceedings over alleged generic drug price fixing in the US to move to trial.
Struggling Teligent underlined the importance of lifting the FDA Warning Letter against its key manufacturing facility in Buena, New Jersey, as its impact slammed the company’s operations last year.
Samsung Bioepis has been tight-lipped on the potential to win approval for its SB11 biosimilar ranibizumab product this year, though new similarity data is a further positive omen for the Korea-based biosimilar player.
Having sat on an approved Vascepa ANDA since August last year, Dr Reddy’s Laboratories has sued originator Amarin, claiming the firm has illegally cornered the market for the hard-to-manufacture active ingredient.