Biogen has conceded that generics to its Tecfidera treatment for relapsing remitting multiple sclerosis may launch “at risk” in the EU, after the US-based player was recently granted further patent protection until 2028.
Biogen says it intends to enforce a newly issued European Tecfidera (dimethyl fumarate) dosing patent against “infringing generics,” but admits that it remains “possible generics may still launch at risk.”
The announcement comes weeks after Sandoz’s Hexal unit confirmed market entry in Germany for its generic version of the treatment for relapsing remitting multiple sclerosis, and with
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.
As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.
As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.
Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.
Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.
