FDA Accepts Samsung Bioepis' BLA for Adalimumab Biosimilar SB5

Samsung Bioepis announced yesterday that the FDA has accepted a Biologics License application (BLA) for its adalimumab biosimilar, SB5, referencing Humira.

The submission included data from a randomized, double-blind, 52-week phase 3 study during which 544 patients with moderate to severe rheumatoid arthritis for whom methotrexate was insufficient were randomized to receive either SB5 or the reference Humira. At week 24, the American College of Rheumatology 20 (ACR20) response rate was 72.4% in the SB5 arm versus 72.2% in the reference arm.

Additionally, the safety profile of SB5 was comparable to the reference up to week 24. At that timepoint, 254 patients receiving the reference product were randomized 1:1 to either continue to take reference adalimumab or switch to SB5, while the original 254 patients taking SB5 continued with that course of treatment.

Researchers found that, up to week 52, the efficacy, safety, and immunogenicity profiles remained comparable between all 3 treatment groups, and there were no treatment emergent issues, nor was there clinically relevant immunogenicity, precipitated by the switch.

The SB5 biosimilar has so far received regulatory approval from a number of agencies outside of the United States, including the European Commission, the Republic of Korea’s Ministry of Food and Drug Safety, Australia’s Therapeutic Goods Administration, and Health Canada.

SB5, under the name Imraldi, is expected to launch the European Union next month, along with several other adalimumab biosimilars, and health systems are beginning to prepare for the arrival of these cost-saving biosimilars.

Among them, the National Health Service (NHS) in the United Kingdom has released patient education materials aimed at answer frequently asked questions, such as background around what biosimilars are and how they’re approved, reasoning behind why the NHS is instituting the switch to biosimilar products for a majority of patients, and identifying where patients can go if they have questions around whether they are suitable candidates for the switch.