Samsung Bioepis presented new data on its adalimumab biosimilar, IMRALDI (SB5), at the European Alliance of Associations for Rheumatology (EULAR) 2022, in Copenhagen, Denmark, on Wednesday.

The phase 1 clinical trial demonstrated pharmacokinetic (PK) equivalence between the new SB5 formulation and the original SB5 formulation.

Both formulations of SB5 were well-tolerated with similar safety profiles. A real-world study called “PROPER” included over 1,000 patients with a diagnosis of rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), ulcerative colitis or Crohn’s disease that were enrolled following the transition to SB5 as part of routine treatment following a minimum of 16 weeks’ treatment with reference adalimumab.

The data captured from patient records retrospectively for 24 weeks before and prospectively and/or retrospectively up to 48 weeks after SB5 initiation showed that treatment effectiveness was maintained at 48 weeks after switching from reference adalimumab to SB5, with most patients continuing on SB5 throughout.

“The addition of new data to our adalimumab biosimilar, SB5, is great news for patients with rheumatic and other inflammatory diseases,” said Shin Dong-hoon, vice president and leader of the Medical &  Lifecycle Safety team at Samsung Bioepis.

Mourad Farouk Rezk, head of Global Medical and Development Biosimilars at Biogen, elaborated, saying, “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.”

The European Commission approved SB5 in August 2017 as a biosimilar to HUMIRA. In Europe, IMRALDI is commercialized by Biogen and BENEPALI (etanercept; SB4) and FLIXABI (infliximab; SB2).

Samsung Bioepis and Biogen’s anti-TNF treatment products assisted about 247,000 patients in Europe alone.

Samsung Bioepis said it would continue to develop data packages for all its products to demonstrate its dedication and commitment to providing quality biologic medicines.

The abstract and poster of the studies are available on the EULAR 2022 website.