Samsung Bioepis and Biogen announce pooled analysis results of anti-TNF biosimilars- Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab) at EULAR 2018.

Samsung Bioepis Co., Ltd. and Biogen announced pooled analysis results of three anti-tumor necrosis factor (anti-TNF) biosimilars – Benepali (SB4, etanercept biosimilar), Flixabi (SB2, infliximab biosimilar), and Imraldi (SB5, adalimumab biosimilar) – which were presented at the Annual European Congress of Rheumatology (EULAR 2018) held June 13–16 in Amsterdam, Netherlands.

Data from three separate Phase III randomized, double-blind studies compared the efficacy and safety of Benepali reference to etanercept (ETN); Flixabi to infliximab (INF); and Imradli to adalimumab (ADL). The data were pooled and analyzed to assess the impact of anti-drug antibodies (ADAbs) on efficacy and tolerability, as well as radiographic progression by disease activity state. Each clinical study had similar study designs and population demographics, and the same primary endpoint of ACR20 response rate. All patients included in the studies had been diagnosed with moderate to severe rheumatoid arthritis (RA) despite previous methotrexate treatment.

Immunogenicity data from 1,710 patients with RA pooled from the three studies revealed that the incidence of ADAb was comparable between the biosimilars and their reference products – indicating that the biosimilars were equally effective as their biologic counterparts. In addition, efficacy and injection site reactions/infusion related reactions (ISR/IRR) were evaluated in relation to the presence of ADAb. Data suggested that the development of ADAb is associated with reduced clinical efficacy and increased incidence of ISR/IRR in patients with RA. 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). Radiographic progression was measured using the modified Total Sharp Score (mTSS) at Week 0 and Week 52 or Week 54. Overall, radiographic progression was minimal and comparable across all treatment groups. In addition, the pooled biosimilar group tended to have a lower mean change in mTSS compared with the pooled reference group, which slows down the progression of this disease.

Since the European Commission granted marketing authorization for Benepali and Flixabi in 2016, the two biosimilars have treated nearly 80,000 patients across 23 countries. As a result of European marketing authorization of Imraldi in 2017, Samsung Bioepis and Biogen expect to launch Imraldi in Europe in October 2018 and, as a result, are on track to become the industry’s first to bring biosimilars referencing products for all three first-generation anti-TNF therapies to European patients and healthcare systems.

The two abstracts presented at EULAR 2018 are as follows: Abstract #THU0201 – A pooled analysis of three TNF-A inhibitor biosimilar studies in patients with rheumatoid arthritis comparing radiographic progression by disease activity states [Poster session: June 14, 2018. Abstract #THU0184 – Impact of immunogenicity on clinical efficacy and administration related reaction in TNF inhibitors: a pooled-analysis from three biosimilar studies in patients with rheumatoid arthritis [Poster tour: June 14, 2018 .