After receiving an approval for the Neulasta rival in the US in May 2022, Kashiv BioSciences has now added a further North American country with a positive nod from Canada’s health agency.
Health Canada has authorized Kashiv BioSciences’ Neulasta (pegfilgrastim) biosimilar, setting it up for commercial launch in the North American country.
The Canadian approval
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Aurobindo’s run of biosimilar registration successes continues, with the firm’s CuraTeQ subsidiary picking up approval for its Zefylti version of filgrastim in the UK.
After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied.
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.
After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied.
Unveiling a new name for its generics business, Hikma has at the same time set out medium-term financial goals for its business that include three-year growth objectives for its sales and profits, as well as aiming at a $5bn turnover target by 2030.
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.
