Imraldi, an investigative biosimilar product to Humira (adalimumab), received a positive review from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as a potential treatment for ankylosing spondylitis and other conditions.
This favorable opinion may help Samsung Bioepis (a venture created by both Samsung BioLogics and Biogen) obtain marketing authorization for Imraldi in the European Union. If approved, Imraldi may become a treatment option for patients with several inflammatory conditions, including ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease.
Humira is estimated to be the No. 1 prescribed biologic therapy in the world, with global sales estimates in 2017 at $16 billion. Similar to Humira, Imraldi acts as a tumor necrosis factor alpha (TNFα) inhibitor.
“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,” Alpna Seth, PhD, Biogen’s senior vice president, said in a press release.
“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,” Seth said. “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 CHMP reviewed data from preclinical and clinical studies comparing the effects of Imraldi and Humira. These data included a Phase 1 trial with healthy individuals, which tested the pharmacokinetics (how the drug is processed in the body) of Imraldi.
It also included a Phase 3 study which investigated the effectiveness and safety of Imraldi and Humira in patients with rheumatoid arthritis. Results showed that both drugs had similar efficacy, as measured by the American College of Rheumatology 20% (ACR20) response after 24 weeks of treatment. Both drugs also had comparable safety profiles.
Ankylosing spondylitis is a form of arthritis that mainly affects the spine, but can also involve other joints, such as shoulders, hips, ribs, heels, and small joints of the hands and feet. This condition is marked by inflammation in the vertebrae, which can be associated with severe, persistent pain and discomfort.
According to the Spondylitis Association of America, the risk factors associated with the disease include testing positive for the HLA-B27 biomarker, having a family history of the disease, and frequent gastrointestinal infections.
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