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The FDA has approved a pair of prefilled autoinjector formulations for the Stelara biosimilar ustekinumab-kfce, according to a press release from the manufacturer.Ustekinumab-kfce...
The US regulator’s decision to move away from subjecting companies to undertake mandatory efficacy trials in phase-3 bodes well for incumbents such as Biocon
Two forces now hitting pharma revenues, and both carry direct implications for employer health plans
By Tyler Novotny and Bryce Platt PBM-affiliated private label biosimilars would seem to have a built-in formulary advantage. But for ustekinumab, that advantage has not carrie...
The Expedited Access to Biosimilars Act enables FDA approval of pharmaceutically equivalent biologic medications.
Alvotech and Lotus Pharmaceutical are teaming up on plans to commercialize AVT87, a proposed biosimilar to Hemlibra (emicizumab). Lisa Graver, CEO of Alvotech, said in a company pr...
Teva believes the therapy has “pipeline-in-a-product” potential. Elsewhere, a high-stakes trial was paused and GSK advanced a competitor to Moderna’s flu shot.
The drugmaker is leaning on a better side effect profile compared to drugs from J&J, Pfizer and Regeneron as it pushes etentamig toward FDA submission.
Pasatru’s approval sets up a market battle in a rare indication where the only available treatment has generated disappointing sales.
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