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Amgen’s biosimilar shows clinical equivalence with Humira

ABP 501 as effective as AbbVie's blockbuster in phase III rheumatoid arthritis trial

Amgen's biosimilar ABP 501 has demonstrated clinical equivalence with AbbVie's Humira in patients with moderate to severe rheumatoid arthritis.

The news is a significant milestone for Amgen and its hopes of bringing to market a biosimilar version of Humira, which was the largest-selling pharmaceutical product last year, raking in sales of $12bn.

The news will also be noteworthy for AbbVie as Humira accounts for 60% of its revenues and is also facing patent expirations at the end of 2016.

However, because biosimilars are typically priced at a 20%-30% discount to the originator drug they do not generally cause the dramatic reduction in brand sales that occur with generics of small-molecule drugs.

The phase III study met its primary endpoint, which was achievement of American College of Rheumatology 20 (ACR20) – an assessment measuring an improvement of 20% or more.

At week 24, 74.6% in the ABP 501 group and 72.4% in the Humira (adalimumab) group met the ACR20 response criteria.

Sean Harper, executive VP of research and development at Amgen, said: “Demonstrating biosimilarity is scientifically complex, but Amgen's 35 years of proven biologic R&D experience is facilitating advancement of exciting programs like ABP 501.

“Our long-term commitment to advancing care in inflammation is as strong as ever, with a portfolio of novel and biosimilar compounds that have the potential to benefit patients worldwide.”

ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-a monoclonal antibody, which is approved for the treatment of numerous inflammatory diseases, including rheumatoid arthritis, moderate-to-severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

Article by
Nikhil Patel

10th November 2015

From: Research



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