Settlement Gives Celltrion Date For US Higher-Strength Humira Biosimilar

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.

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.