Samsung Bioepis Humira biosimilar demonstrates clinical equivalence

South Korea’s Samsung Bioepis says that its pivotal Phase III clinical study of SB5, an investigational biosimilar of AbbVie’s (NYSE: ABBV) Humira (adalimumab), met its primary endpoint, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy.

The primary endpoint was the American College of Rheumatology 20% response criteria (ACR20), at week 24. At week 24, the ACR20 improvement from baseline was within the pre-specified equivalence margin for SB5 compared to adalimumab, says the company, which is a joint venture between Samsung Biologics (majority owner) and Biogen (Nasdaq: BIIB).

"We have developed SB5 following SB4 and SB2. Now we have developed biosimilars for three of the best-selling biologics for autoimmune disease.” said Christopher Hansung Ko, chief executive officer at Samsung Bioepis, adding: "We look forward to providing increased access to patients suffering from autoimmune diseases within the same healthcare budget, and consequently bend the curve of rising healthcare costs worldwide"

Other biosimilars in the Bioepis pipeline