A biosimilar candidate to Humira (adalimumab), Amgevita (ABP 501), was recommended for EU approval by the Committee for Medicinal Products for Human Use (CHMP) as a treatment of moderate to severe chronic plaque psoriasis in adults, and of severe chronic plaque psoriasis in children (ages 4 and older) who cannot use or do not respond to topical therapy and phototherapy.
Amgevita, developed by Amgen, is an anti-TNF-alpha monoclonal antibody with the same structure and action, pharmaceutical dosage form, and strength as Humira. It blocks TNF (tumor necrosis factor) pro-inflammatory activity and its induced or regulated immune responses.
Humira is an approved plaque psoriasis treatment in both the U.S. and EU. The U.S. Food and Drug Administration (FDA) approved ABP 501, under the brand name Amjevita (adalimumab-atto), as a treatment for multiple inflammatory diseases in September, including for adults with moderate to severe plaque psoriasis.
The biosimilar is available as solution for injection, and is intended for EU use as monotherapy or in combination with methotrexate for the treatment rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis, and uveitis.
Clinical studies showed that ABP 501 had comparable quality, safety and efficacy to Humira. Two Phase 3 studies conducted in patients with moderate-to-severe plaque psoriasis (NCT01970488) and moderate-to-severe rheumatoid arthritis (NCT02114931), reported no significant differences between the two treatments. These results, together with data supporting the transition of patients from Humira treatment to ABP 501, were key to CHMP ruling in favor of marketing authorization (CHMP is an arm of the the European Medicines Agency, or EMA).
The CHMP opinion will now be reviewed by the European Commission for a final decision, and if approved the drug will be available throughout the European Union. Countries that are members of the European Economic Area alone, such as Norway, Iceland and Liechtenstein, usually act based on the commission’s decision.
“The positive CHMP opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU,” Sean E. Harper, executive vice president of Research and Development at Amgen, said in a press release. “This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”
Amgevita was reported to have side effects similar to those possible with Humira. These include a higher risk of developing serious infections, particularly when taken together with immunosuppressive drugs. In children and adolescents, cases of lymphoma and other malignancies have been recorded.