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news.Amgen has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for adalimumab biosimilar candidate, ABP 501, to treat several inflammatory diseases.
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It is the first adalimumab biosimilar candidate recommended for EMA approval. It has been recommended to treat certain inflammatory ailments in adults like moderate-to-severe rheumatoid arthritis, severe ankylosing spondylitis (AS), psoriatic arthritis, moderate-to-severe ulcerative colitis, severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe Crohn's disease among others.
The committee also recommended its approval for certain pediatric inflammatory ailments as well.
Amgen stated that ABP 501’s Marketing Authorization Application (MAA) submission was done after securing positive results from two phase 3 studies of the biosimilar candidate carried out in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients.
Both the phase 3 studies of ABP 501 met their respective primary endpoints, demonstrating no clinically meaningful differences to adalimumab. Amgen added that the biosimilar’s safety and immunogenicity were on par with adalimumab.
Amgen research and development executive vice president Sean E. Harper, M.D. said: "The positive CHMP opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU.”
"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."
The adalimumab biosimilar from Amgen is an anti-TNF-α monoclonal antibody which was approved in the US in September 2016 under the brand name Amjevita. It was also approved in some other regions for the treatment of various inflammatory diseases.