EU Commission Approves Drug for Select Adult, Pediatric Inflammatory Diseases

The European Commission today granted marketing authorization for the adalimumab (Amgevita/Amgen), a biosimilar that can treat certain inflammatory diseases in adults and some pediatric inflammatory diseases.

According to researchers, inflammatory diseases in adults include: moderate-to-severe rheumatoid arthritis, psoriatic severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn's disease, and moderate-to-severe ulcerative colitis.

Pediatric patients have appeared to find relief from the following conditions with adalimumab: moderate-to-severe Crohn's disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older), and polyarticular juvenile idiopathic arthritis (ages two and older).

The approval was based on analytical, pharmacokinetic, and clinical data supporting “biosimilarity” to adalimumab, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The research team reported no clinically meaningful differences to adalimumab. The active ingredient of Amgevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as, and is highly similar to, adalimumab. Safety and immunogenicity of AMGEVITA were also comparable to adalimumab.

In case of intolerance to methotrexate or when continued treatment with methotrexate (Rheumatrex, Trexall) is inappropriate, the medication can be given as monotherapy — it works by reducing the rate of progression of joint damage and improves physical function, when given in combination with methotrexate.

To meet the approved dosage recommendations for each indication, the biosimilar will be delivered in prefilled syringe and auto injector presentations.

The US Food and Drug Administration already approved Amgevita in the United States on September 26, 2016.