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Home Industry News Amgen receives CHMP backing for biosimilar adalimumab

Amgen receives CHMP backing for biosimilar adalimumab

2nd February 2017

Amgen has announced that its new biosimilar version of adalimumab has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for the marketing authorisation of the biosimilar ABP 501, recommending approval for all available indications.

This includes the treatment of certain inflammatory diseases in adults, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, chronic plaque psoriasis, hidradenitis suppurativa, Crohn's disease and ulcerative colitis.

The biosimilar – which has also been recommended for the treatment of certain paediatric inflammatory diseases – is the first adalimumab biosimilar candidate recommended for European Medicines Agency approval.

A comprehensive data package has supported ABP 501's biosimilarity to adalimumab based on analytical, pharmacokinetic and clinical data, including results from two phase III studies conducted in moderate to severe plaque psoriasis and rheumatoid arthritis patients.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "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."

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