Topline results for Hadlima biosimilar in interchangeability study

Biosimilars/Research | Posted 10/10/2023 post-comment0 Post your comment

Samsung Bioepis and Organon announced topline results from interchangeability study of their Humira biosimilar, SB5/Hadlima, in August 2023.

Interchangeability V18K30

SB5 was first approved by the US Food and Drug Administration (FDA) in July 2019 under the brand name Hadlima (adalimumab-bwwd) as a low-concentration (50 mg/mL) formulation of pre-filled syringe and pre-filled autoinjector [1]. The high-concentration (100 mg/mL) formulation of prefilled syringe and pre-filled autoinjector of Hadlima was approved in August 2022 [2]. Hadlima was introduced into the US commercial market on 1 July 2023 and is marketed by Organon.

This recent study was a phase IIII, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicentre clinical study (NCT05510063). The primary objective of the study was to assess the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between Humira and high-concentration SB5/Hadlima versus patients receiving Humira continuously. It was conducted across 33 sites in four countries (Bulgaria, Czechia, Lithuania, Poland) from August 2022 to May 2023 in patients with moderate to severe chronic plaque psoriasis. Overall, the study achieved all primary endpoints (pharmacokinetic endpoints of area under the curve(AUC)tau and maximum concentration (Cmax) at Week 23‒25). Efficacy profiles, safety profiles, and immunogenicity were also comparable between two treatment groups.

The originator, AbbVie’s Humira (adalimumab) is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Humira (adalimumab), was first approved by FDA in December 2002 and by the European Medicines Agency in September 2003 [3].

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1. GaBI Online - Generics and Biosimilars.  Initiative. Biosimilars approved in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 10]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative.  Biosimilars of adalimumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 10]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for high concentration adalimumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 10]. Available from:

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