The European Medicines Agency (EMA) has accepted a marketing authorization application from generic pharmaceuticals developer Sandoz for the review of biosimilars for AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab), used in the treatment of autoimmune diseases. Remicade is widely used for rheumatoid arthritis (RA) therapy.
Biosimilars are biopharmaceutical drugs that have similar properties to other licensed therapies. Sandoz announced the acquisition of the rights to Pfizer’s biosimilar to infliximab (PF-06438179) in the European Economic Area as a possible treatment for RA and psoriasis in February 2016.
With this new marketing authorization application, the company seeks approval for the two biosimilars for use in all indications of their respective reference medicines.
EMA accepted the marketing authorization application based on comprehensive data demonstrating that each biosimilar matches its respective reference medicine regarding quality, effectiveness, and safety. Analytical, preclinical, and clinical data demonstrate the biosimilarity of the proposed medicines to their references, the company stated.
The submission for Humira’s biosimilar included data from pharmacokinetic studies as well as the Phase 3 effectiveness and safety study, (NCT02016105), in patients with moderate to severe chronic plaque psoriasis.
The submission for Remicade’s biosimilar included clinical data from a pharmacokinetics study and the Phase 3 effectiveness and safety trial, (NCT02222493), in patients with RA.
This trial enrolled RA patients with active disease and an inadequate response to methotrexate alone. Its primary outcome measurement was the number of participants with an ACR20 (American College of Rheumatology 20%) response at 14 weeks, or at least 20% improvement in tender joint count, swollen joint count, pain, and disease activity, among others. The study is expected to be completed by the end of 2017.
“Patients with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease rely on biologic medicines like adalimumab and infliximab to stay well, but unfortunately access to these essential medicines can be limited,” Mark Levick, MD, PhD, Sandoz’s global head of development, said in a press release.
“The EMA’s acceptance of our regulatory submissions for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline,” Levick added.
Sandoz already has received positive feedback from European health agencies over its biosimilar portfolio. Its latest regulatory submissions follow two previous positive opinions from the Committee for Medicinal Products for Human Use for two biosimilar medicines aimed at treating blood cancers.
The company is on track to launch five biosimilars of major oncology and immunology biologics, including Humira and Remicade, by 2020.
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