Amgen's Phase 3 study reveals positive findings

Amgen’s Phase 3 study assessing the safety and effectiveness of biosimilar candidate ABP 501 versus Humira in patients with moderate to severe rheumatoid arthritis has revealed positive results, according to a Tuesday report.

The study showed scientific equality of ABP 501 to Humira in comparable immunogenicity and safety, as well as overall effectiveness, Amgen's Executive Vice President of Research and Development Sean Harper said.

The study met its primary and secondary endpoints. In the primary endpoint, ACR20 measurements of the two products were compared during week 24, with equality revealed as the ACR20 was within the stipulated margin when ABP 501 was compared to Humira. Secondary endpoints included similar tests with ACR50, ACR70 and DAS 28-CRP.

“Amgen's success on both our ABP 501 psoriasis and rheumatoid arthritis studies underscores our expertise in the research and development of high-quality biologic therapies," Harper said. "Inflammation remains a core therapeutic area for Amgen, and we are committed to leveraging our long-term heritage in the space to deliver a portfolio of biosimilar and novel compounds that benefit patients worldwide."

Amgen is developing ABP 501 as a biosimilar contender to Humira, which is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and other inflammatory diseases.

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