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Amgen Submits BLA For ABP 710 To FDA - Quick Facts

Amgen Inc. (AMGN) said Monday that it has submitted a Biologics License Application or BLA to the U.S. Food and Drug Administration for ABP 710, a biosimilar candidate to Remicade, or infliximab.

ABP 710 is being investigated as a biosimilar candidate to infliximab, an anti-tumor necrosis factor alpha or anti-TNF monoclonal antibody, which is approved in many regions for the treatment of moderate to severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate to severe Crohn's disease, moderate to severe ulcerative colitis, psoriatic arthritis and ankylosing spondylitis.

Amgen noted that the BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in patients with moderate-to-severe rheumatoid arthritis and confirmed no clinically meaningful differences between ABP 710 and infliximab.

"We're leveraging our deep expertise and heritage in biologics to produce a portfolio of biosimilars to serve patients with the most complex diseases. We're committed to providing patients with serious illnesses access to high-quality biological therapies and look forward to working with the FDA to potentially bring ABP 710 to market," aid David Reese, executive vice president of Research and Development at Amgen.

Amgen has a total of 10 biosimilars in its portfolio, including two that are approved in the U.S. and three that are approved in the European Union or EU.

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