Brenzys (etanercept biosimilar) approved in South Korea for rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and psoriasis- Merck and Samsung Bioepis

Merck and Samsung Bioepis Co announced the approval of Brenzys (etanercept), a biosimilar of the immunology medicine Enbrel previously known as SB4, by the Ministry of Food and Drug Safety (MFDS) in Korea. Brenzys is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis) and psoriasis in adult patients (age 18 years and older). The approval of Brenzys in Korea represents the first product approval under Merck’s collaboration with Samsung Bioepis, which is designed to offer high-quality biosimilar alternatives to existing biologic medicines to help address patient and healthcare system needs worldwide. Merck plans to launch Brenzys in South Korea by the end of this year or early next year.

The MFDS approval of Brenzys was based on data from a Phase I study in 138 healthy male subjects and a Phase III randomized clinical study in 596 patients with rheumatoid arthritis (RA). In the Phase III study, RA patients were randomized to receive either 50mg of Brenzys or 50mg of Enbrel subcutaneously once weekly for up to 52 weeks. The primary endpoint was the American College of Rheumatology 20 percent response criterion (ACR20) at week 24, and the results showed an equivalent efficacy and safety profile for Brenzys to originator etanercept. The results of the Phase I and Phase III studies were presented at the Annual Congress of the European League Against Rheumatism (EULAR) held in Rome, Italy, on 10–13 June 2015. Subsequently, the Phase III study results were published in EULAR’s official medical journal, Annals of the Rheumatic Diseases.