On August 2nd, Samsung Bioepis, under the leadership of CEO Hansung Ko, declared the positive outcome of the interchangeability clinical trial for SB5, marketed as Hadlima in the United States, a biosimilar of Humira.

The interchangeability clinical trial aimed to investigate any impacts on the immune response or pharmacokinetic (PK) profiles when transitioning between the reference drug and the biosimilar. The primary objective of the study was to assess the interchangeability between the two products.

From August 2022 to May 2023, Samsung Bioepis conducted an interchangeability clinical trial in Poland, the Czech Republic, Bulgaria, and Lithuania, enrolling 371 patients suffering from moderate to severe chronic plaque psoriasis.

Throughout the clinical trial, all patients received the original drug from week 0. Then, from week 13 onwards, they were randomly assigned to two groups: one group continued receiving the original drug (maintenance group), while the other received a combination of SB5 and the original drug in a cross-over manner (cross-over group).

The primary endpoints of the interchangeability clinical trial were the assessment of the Area Under the Concentration-time curve (AUCtau) and Maximum serum Concentration (Cmax) from weeks 23 to 25. The results demonstrated the successful achievement of all primary endpoints of AUCtau and Cmax. Moreover, both treatment groups showed comparable efficacy profiles, safety profiles, and immunogenicity.

The company official confirmed the fulfillment of the primary endpoints in the interchangeability clinical trial of the Humira biosimilar product and outlined the subsequent procedures for obtaining relevant regulatory approval.