Samsung Bioepis Gains EU Approval for Adalimumab Biosimilar

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, announced today that it has received the European Commission’s (EC) approval for its adalimumab biosimilar (Imraldi), referenced on AbbVie’s blockbuster Humira. The marketing authorization indicates treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, and uveitis.

With today’s approval, Samsung Bioepis now holds EC approvals for 3 anti—tumor necrosis factor (TNF)-alpha drugs. Its etanercept biosimilar (Benepali) and its infliximab biosimilar (Flixabi) were both authorized for marketing in Europe in 2016.

“We are proud to become the industry’s first to obtain European approval for a third TNF inhibitor. This is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.”

The approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June of 2017. The CHMP based its opinion on a clinical data package that included results from 2 head-to-head studies: a phase 1 study in healthy volunteers that demonstrated pharmacokinetic bioequivalence between the biosimilar and its reference, and a phase 3, randomized, double-blind, multicenter study in which the biosimilar demonstrated equivalent efficacy and comparable safety and immunogenicity to the reference. The phase 3 study met its primary endpoint of producing, by week 24, a response of ACR20 (or the American College of Rheumatology 20% improvement in tender and swollen joint counts; patient assessments of pain, global disease activity, and physical function; physician global assessment of disease activity; and acute phase reactant).

Adalimumab is the top-selling drug in the world, and earned $16.08 billion in sales in 2016. Spending on adalimumab in the European marketplace accounted for approximately $9 billion. Biogen estimates that market entry of Imraldi could generate $3.18 billion in savings for European health systems by 2020.

Additional biosimilar developers hoping to challenge AbbVie for adalimumab market share include Choerus BioSciences, which is developing CHS-1420, and Boehringer Ingelheim (BI), which is developing BI 695501. BI announced in July that it has enrolled patients in a first-of-its-kind study to demonstrate interchangeability of its molecule with that of the reference adalimumab.