The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion Biogen’s adalimumab biosimilar, SB5 (also known as Imraldi), referencing Humira.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion on Biogen’s adalimumab biosimilar, SB5 (also known as Imraldi), referencing Humira. CHMP’s opinion will now be reviewed by the European Commission, which is expected to grant a marketing authorization for the drug in the European Union.
CHMP’s positive opinion is based on preclinical and clinical data comparing the biosimilar to its reference product. The clinical data include results of a phase 1 study in healthy volunteers that demonstrated pharmacokinetic (PK) equivalence between Humira and a phase 3, randomized, double-blind, multicenter study in which the biosimilar demonstrated equivalent efficacy and comparable safety and immunogenicity profiles to the reference product in patients with rheumatoid arthritis. 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).
SB5 is the third anti—tumor necrosis factor (anti–TNF) biosimilar candidate submitted to the EMA by Samsung Bioepis, a joint effort between Biogen and Samsung BioLogics. Alpna Seth, PhD, senior vice president and global head of the biosimilars business unit at Biogen, said, “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.”
In its official statement, Biogen estimates that the European market for anti—TNF drugs accounts for the equivalent of $9 billion in healthcare costs. Of that total cost, Humira accounts for $4 billion. While market analysts expect the reference adalimumab to remain the top-selling drug by 2022, the introduction of such biosimilar products as SB5, Amgen’s adalimumab biosimilar (known as Amjevita) that was granted its own positive opinion in January, or any of the 3 additional adalimumab biosimilar candidates currently under consideration at the EMA could exert considerable pressure on AbbVie to offer its reference product to European health systems at a more competitive price.