Following a years-long back-and-forth to establish exclusivity protection for its Tecfidera multiple-sclerosis treatment in Europe, Biogen has ultimately seen the CHMP recommend three generic versions to receive pan-European marketing authorization.
With the US market cannibalized following several generic launches, Biogen, Inc. had earlier this year warned that generic competition to its Tecfidera (dimethyl fumarate) brand in the EU could appear “as early as the first half of 2022” as it continues efforts to overturn an unfavorable ruling that chopped the drug’s data- and marketing-protection periods.
The outcome of the originator’s ongoing challenges to Tecfidera’s exclusivity was “difficult to predict,”
Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.
Gedeon Richter’s CEO has urged analysts and the firm itself to give more attention to its “unfairly neglected” General Medicines division – which includes both generics and licensed-in innovative products – during the Hungarian firm’s first-quarter earnings call.
Rejecting Amgen’s challenges on the grounds of anticipation and obviousness, Canada’s Federal Court has issued an injunction against the biosimilars firm until patent expiry in March 2027.
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.
With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.
The Belgian value-added medicines specialist company struck two commercialization deals over its novel valacyclovir oral suspension that span three continents, marking a further milestone in the product’s development.
