Samsung Bioepis’ Humira biosimilar meets primary endpoints in phase 3 RA trial

Samsung Bioepis has announced that its biosimilar to Humira has met its primary endpoint in a phase 3 trial by demonstrating equivalence to the original in the treatment of moderate-to-severe rheumatoid arthritis, according to a company press release.

Efficacy was measured by an American College of Rheumatology response (ACR) of 20% improvement in symptoms (ACR20) at week 24. Patients who received the biosimilar, currently named SB5, met ACR20 by the margins outlined in the study.

According to the press release, the active ingredient in SB5 has the same amino acid sequence as Humira (adalimumab, AbbVie) and was prescribed at the same dosage, strength and delivery method as is recommended for adalimumab in the trial.

Adalimumab is currently approved in the U.S. and throughout Europe for the treatment of rheumatoid arthritis (RA), plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. Biosimilars are not approved in the U.S. at this time but have been approved in Europe, parts of Asia and elsewhere.

“We have developed SB5 following SB4 and SB2. Now we have developed biosimilars for three of the best-selling biologics for autoimmune disease.” Christopher Hansung Ko, PhD, CEO at Samsung Bioepis, said in the release. “We look forward to providing increased access to patients suffering from autoimmune diseases within the same health care budget and consequently bend the curve of rising health care costs worldwide.”

Reference : www.samsungbioepis.com.