Samsung Bioepis Demonstrates Equivalence in Clinical Trial of 'High-Concentration' Humira Biosimilar

[Asia Economy Reporter Jang Hyowon] It has been reported that the equivalence between Samsung Bioepis's 'high-concentration' Humira (active ingredient adalimumab) biosimilar and the previously approved low-concentration formulation has been demonstrated in clinical trials.

According to the pharmaceutical and bio industry on the 1st, Samsung Bioepis disclosed the Phase 1 clinical trial results of the high-concentration adalimumab biosimilar 'SB5' at the '2022 European League Against Rheumatism Annual Congress' (EULAR Congress 2022) held in Copenhagen, Denmark, starting from that day.

This clinical trial aimed to compare the characteristics of Samsung Bioepis's newly developed high-concentration formulation (40mg/0.4ml) of the adalimumab biosimilar with the existing low-concentration formulation (40mg/0.8ml).

From August 2020 to May last year, the trial was conducted on 188 healthy adult males in Germany, confirming that the pharmacokinetic properties?absorption, distribution, metabolism, and excretion?and safety between the two formulations were biologically equivalent.

This is the first time the clinical results of the SB5 high-concentration formulation developed by Samsung Bioepis have been disclosed. Samsung Bioepis has obtained approval for the Humira biosimilar SB5 under the names 'Imraldi' in Europe and 'Hadlima' in the United States, but developed the high-concentration formulation additionally to meet field demand. The high-concentration product is known to be preferred by patients due to a lower drug administration volume compared to the existing product. AbbVie, the original drug manufacturer of Humira in the United States, is also targeting the market with a high-concentration formulation.

Since similarity with the previously approved product was confirmed in Phase 1 clinical trials, industry insiders expect that the ongoing U.S. Food and Drug Administration (FDA) approval review will proceed smoothly.

Samsung Bioepis has already received FDA approval for SB5 in the U.S., so it is following a supplemental approval process by submitting additional data without conducting Phase 3 clinical trials.

According to a patent agreement with AbbVie, the original drug holder of Humira, Samsung Bioepis plans to launch the biosimilar in the U.S. after July next year.

In Europe, the patent for Humira has already expired. SB5 was launched under the name Imraldi in Europe in October 2018 and is currently on sale. Imraldi holds about 13% of the total European adalimumab drug market.

This content was produced with the assistance of AI translation services.