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.
Unlocking Biosimilar Potential in Specialty Pharmacies With Legislative Support, Formulary Changes
April 24th 2025Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that legislative support and formulary changes are crucial for overcoming unique challenges in specialty pharmacies and driving the growth of biosimilar adoption, which has significant cost saving potential in the next decade.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Biosimilar and Biologic Use Increasing in Greek Patients With IBD
April 19th 2025A retrospective study from a single inflammatory bowel disease (IBD) center in Greece reported that from 2018 to 2022, the use of biologics increased by 28% yearly, and the proportion of patients using biosimilars grew from 33% to 67%.