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CHMP issues positive opinion for Amgens adalimumab biosimilar
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Today, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the marketing authorization of Amgen’s ABP 501, an adalimumab biosimilar for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, panuveitis, Crohn’s disease and ulcerative colitis, according to a company release.
“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, MD, executive vice president of Research and Development at Amgen, said in the 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.”
The positive opinion also recommends ABP 501 — an anti-tumor necrosis factor inhibitor — for Crohn’s disease in patients aged 6 years and older, chronic plaque psoriasis in patients aged 4 years and older, enthesitis-related arthritis in patients aged 6 years and older and polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.
The marketing authorization application used two phase 3 studies of patients with plaque psoriasis and rheumatoid arthritis.
The FDA approved ABP 501 on September 23.
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