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Amgen has announced positive results from a clinical study evaluating the safety and efficacy of biosimilar candidate, ABP 501, compared with Humira (adalimumab) in patients with moderate-to-severe rheumatoid arthritis.
Amgen has announced positive results from a clinical study evaluating the safety and efficacy of biosimilar candidate, ABP 501, compared with adalimumab (Humira, Abbott Laboratories) in patients with moderate-to-severe rheumatoid arthritis.
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis. The active ingredient in ABP 501 is also an anti-TNF-α monoclonal antibody with the same amino acid structure as adalimumab. ABP 501 has the same dosage form and strength as adalimumab as well.
The phase 3 study comparing the safety and efficacy of ABP 501 with adalimumab included 526 adult patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate in the past. The participants were randomly assigned to receive either ABP 501 or adalimumab every 2 weeks. The study consisted of a 4-week screening period and a 22-week treatment period, followed by a 26-week safety follow-up period.
The primary end point of the study compared the ACR20 measurements (20% or greater improvement in ACR assessment) at week 24. ACR is a scale to measure change in rheumatoid arthritis symptoms and is named after the American College of Rheumatology. The results were within the prespecified margin for ABP 501 compared to adalimumab, showing clinical equivalence.
Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Key secondary end points included ACR50, ACR70, as well as DAS 28-CRP, which is a disease activity score calculator for rheumatoid arthritis. The study showed positive top-line results for all primary and secondary end points.
“We anticipate that our studies will form the basis for global regulatory submissions,” said Kelley Davenport, Amgen spokesperson. “When biosimilars, not just Amgen's, are approved by FDA, we expect that they will play a role in providing additional therapeutic alternatives for some patients and in potentially reducing the cost of delivering important biotechnology medicines.”
Amgen has 9 biosimilar molecules in development and expects to launch 5 of these between 2017 and 2019.
Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.