Coherus BioSciences has swiftly returned a filing for its on-body pegfilgrastim biosimilar candidate to the US Food and Drug Administration, while hitting a milestone for its Cimerli biosimilar to Lucentis (ranibizumab).
Coherus BioSciences has resubmitted to the US Food and Drug Administration its filing for the company’s version of Amgen’s Neulasta (pegfilgrastim) Onpro on-body injector device using Coherus’ Udenyca (pegfilgrastim-cbqv) biosimilar, weeks after an FDA complete response letter stopped the firm in its tracks.
The California-based firm has reiterated that it is “committed to working closely with the FDA,” anticipating
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.
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.
Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.
