The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Imraldi (also known as SB5), an adalimumab biosimilar candidate referencing Humira. The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). Imraldi marks the third anti-TNF candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen.

If approved by the EC, Imraldi would be approved for the treatment of rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa and non-infectious uveitis.

The anti-TNF market alone accounts for an estimated $9 billion of healthcare expenditures in Europe, of which Humira accounts for $4 billion. Global sales estimates for Humira stand at $16 billion in 2017, making it the number-one prescribed biologic therapy in the world. Earlier this year, data were unveiled at the ISPOR 22nd Annual Meeting in Boston showing that biosimilar introduction of the top-three anti-TNF therapies in Europe could result in savings of $11.44 billion by 2020. Of these savings, $3.18 billion could be attributed to prescribing an adalimumab biosimilar referencing Humira, despite only being approved near the end of the study period.

“If Imraldi receives approval, Biogen will be the first company to have approved biosimilars of the three most prescribed anti-TNF biologic treatments in Europe,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “This portfolio expansion is in line with our mission to increase access to biologics that have transformed the treatment of chronic autoimmune conditions like rheumatoid arthritis. Being able to provide this range of anti-TNF treatment alternatives bolsters our leadership position and underscores our commitment to expanding physician choice, while supporting the sustainability of healthcare systems.”

The positive opinion is based on a robust preclinical and clinical data package comparing Imraldi with Humira. The clinical data include results from two head-to-head studies – a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira and a Phase III, randomized, double-blind, multicenter study, in which Imraldi demonstrated equivalent efficacy and comparable safety and immunogenicity to Humira in patients with RA. The primary endpoint of the Phase III study, the American College of Rheumatology 20% (ACR20) response at Week 24, was met, demonstrating equivalent efficacy to Humira.6 Secondary endpoints demonstrated that Imraldi has a comparable safety and immunogenicity profile to Humira.