Shots:Biocon Biologics & Amgen have entered into a settlement & license agreement, allowing the US launch of Bosaya (60mg/mL, SC, PFS) & Aukelso (70mg/mL, SC, single-dose vial), provisional interchangeable biosimilars to Prolia & Xgeva (denosumab) by Oct 1, 2025Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya…
Shots:The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab)Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia…
Shots:FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vialDesignation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO…
Shots:The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…

