Samsung Biopepis is stepping up efforts to enlarge its share in the European biosimilar market.
The company said it would announce clinical results on three biosimilar products at the European League Against Rheumatism (EULAR), to be held in Amsterdam, the Netherlands, through Saturday.
The three treatments are benepali (Enbrel biosimilar), Flixabi (Remicade biosimilar), and Imraldi (Humira biosimilar).
Samsung Bioepis plans to disclose pooled data from three separate phase-3 studies to assess the impact of anti-drug antibodies (ADA) on efficacy and tolerability, as well as radiographic progression by disease activity state, according to the company.
The biosimilar manufacturer said data from 1,710 patients with rheumatoid arthritis (RA) showed that the incidence of ADA was similar between the biosimilars and their reference drugs.
Radiographic data from 1,263 patients participating in the studies were collected and grouped based on patient’s disease activity state at the time of the primary endpoint assessment (Week 24 or Week 30).
The company also divided 1,263 patients into three groups by the severity of their symptoms. Results of the comparisons between the biosimilars and the originals revealed that the biosimilar group had a lower radiographic progression than that of the original group.
Winning approval for Benepali in January 2016 for the first time, Samsung Bioepis has obtained the nod for five biosimilar products to date.
Europeans have a high degree of understanding about biosimilars thanks to ongoing education. They also have a strong commitment to reducing drug costs through generics or biosimilars.
Europe has adopted a system to give incentives to hospitals and physicians if they cut medical costs through biosimilars. The atmosphere there is entirely different from that of the U.S. where private insurance firms lead the healthcare system.
Due to such reasons, not only Samsung Bioepis but other drugmakers such as Celltrion and Pfizer are putting efforts to lay the groundwork in Europe first.
“Celltrion is already using an aggressive strategy to encourage drug switching to biosimilars in Europe, a pharmaceutical source said. “Samsung Bioepis is also seeking a more share in Europe by disclosing various clinical data.”
<© Korea Biomedical Review, All rights reserved.>