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.