Data showing the clinical outcomes of Samsung Bioepis’ biosimilar referencing Humira (adalimumab) were shared at the European Congress of Rheumatology’s annual meeting, EULAR 2022.
Samsung Bioepis shared new data from a phase 1 study and a real-world study showing the clinical outcomes associated with its adalimumab biosimilar (Imraldi; Hadlima; SB5), which references Humira, at the EULAR 2022 conference.
EULAR 2022 is the European Congress of Rheumatology’s annual meeting. It is being held in Copenhagen, Denmark, from June 1 through June 4. Imraldi was developed by Samsung Bioepis and Biogen and was approved for use in the European Union in August 2017.
“The addition of new data to our adalimumab biosimilar, SB5, is great news for patients with rheumatic and other inflammatory diseases….Samsung Bioepis has been constantly developing our data package for all our products and we are very pleased to be providing additional evidence which further demonstrates our dedication and commitment to providing quality biologic medicines,” said Donghoon Shin, vice president and medical and lifecycle safety team leader at Samsung Bioepis, in a company statement.
In the randomized, single-blind, 2-arm, parallel group, single-dose phase 1 study, the pharmacokinetics, safety, and tolerability profiles of the new formulation of SB5 (40 mg/0.4 mL) were compared with the original formulation (40 mg/0.8 mL) in healthy male participants. The results demonstrated the clinical equivalence between the 2 formulations.
The PROPER study was a pan-European real-world study sponsored by Biogen. The study was intended to provide insight into the outcomes related to switching from Humira to SB5. Overall, more than 1000 patients with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, ulcerative colitis, or Crohn disease were enrolled after transitioning to the biosimilar after at least 16 weeks of treatment with the reference product.
Data on the patients were captured for 24 weeks prior to the transition through 48 weeks after switching to SB5. The study demonstrated that the effectiveness of adalimumab therapy remained after 48 weeks on the biosimilar, with most patients choosing to continuing treatment with SB5.
“We are very pleased with the results of the PROPER study which adds to the body of real-world evidence for our biosimilars, offering significant clinical insights for treatment optimization of patients with rheumatoid arthritis….Real-world evidence from studies like PROPER can provide meaningful insights on the use of anti-TNF biosimilars in clinical settings and can advance the understanding of their potential role in managing chronic immune mediated inflammatory diseases,” said Mourad Farouk Rezk, head of Global Medical and Development Biosimilars at Biogen.
SB5 was approved by the FDA in July 2019. When the biosimilar launches on the US market in July 2023, it will be marketed under the name Hadlima and it will be commercialized by Organon. Samsung Bioepis received the approval for a low-concentration formulation and a high-concentration, citrate-free formulation of Hadlima. SB5 was made available to patients in Australia in March 2021.
Samsung Biopeis and Biogen also share European commercialization rights for Benepali (etanercept biosimilar; SB4) and Flixabi (infliximab biosimilar; SB2).