At the latest meeting of the EMA’s CHMP committee, the agency recommended that Amgen be granted a third European marketing authorization for a Stelara biosimilar.
Amgen has become the third firm to win a positive opinion from the European Medicines Agency for a Stelara (ustekinumab) biosimilar, after its Wezenla version was endorsed by the agency’s Committee for Medicinal Products for Human Use in its April meeting.
While CHMP positive opinions do not constitute formal approval, the European Commission typically acts within 67 days to convert
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.
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.
