Imraldi, Candidate for Humira Biosimilar, Is Step Closer to Approval in Europe

Imraldi, Candidate for Humira Biosimilar, Is Step Closer to Approval in Europe

Samsung Bioepis received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on its marketing application for Imraldi, a Humira (adalimumab) biosimilar candidate.

The application is for the treatment of several inflammatory autoimmune diseases, including polyarticular juvenile idiopathic arthritis and rheumatoid arthritis.

The application now goes to the European Commission, which makes the final decision about marketing authorization for medications in the European Union. If approved, Imraldi will help expand the therapeutic options available to patients with chronic inflammatory illnesses while reducing their financial burden.

Treatments targeting TNF, a protein involved in inflammation, are important therapeutic tools for patients with inflammatory diseases, representing an estimated value of $9 billion in healthcare expenses in Europe. Of this amount, $4 billion is to cover the costs related to prescriptions of Abbvie’s anti-TNF drug Humira.

The introduction of biosimilar drugs into the market can reduce these expenses while maintaining healthcare efficacy and safety. Indeed, the introduction of three anti-TNF biosimilar therapies in Europe could represent a savings of about $11.44 billion by 2020, according to results shown at the ISPOR 22nd Annual Meeting held in Boston.

CHMP’s positive opinion for the biosimilar candidate Imraldi, also known as SB5, was based on data from preclinical and clinical programs developed by Samsung Bioepis, the collaborative project between Samsung BioLogics and Biogen.

Results of a Phase 1 (NCT02144714) clinical study in healthy volunteers, and the pivotal Phase 3 (NCT02167139) trial in adult patients with moderate to severe rheumatoid arthritis, demonstrated that Imraldi’s activity, effectiveness, and safety profile were similar to those described for its referencing therapy, Humira.

“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, senior vice president and global head of the Biosimilars Business Unit at Biogen, 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.”

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