The sBLA submission was based on the results from the P-IV clinical trial (NCT05510063) evaluating the PK of Hadlima in 2 treatment groups of patients with severe plaque psoriasis who alternatively received high-concentration formulations of Humira or Hadlima vs patients receiving Humira continuously
Samsung Bioepis submitted the sBLA for Hadlima, a tumor necrosis factor (TNF) blocker, to the US FDA on Aug’23 post which the filling has progressed for interchangeability designation
Earlier in Jul’19, Hadlima received the US FDA’s approval as a low-concentration (40 mg/0.8 mL) formulation of the prefilled syringe & prefilled autoinjector whereas its high concentration (40 mg/0.4 mL) formulation was approved in Aug’22 (marketed across the US by Organon)
Ref: Organon | Image: Samsung Bioepis
Related News:- Organon and Samsung Bioepis Launch Hadlima (biosimilar, adalimumab)
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