"At Amgen, we have spent nearly four decades developing, manufacturing and producing transformative medicines. We're leveraging our deep expertise and heritage in biologics to produce a portfolio of biosimilars to serve patients with the most complex diseases," said
ABP 710 is being investigated as a biosimilar candidate to infliximab, an anti-tumor necrosis factor alpha (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.
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.
About ABP 710
ABP 710 is being developed as a biosimilar candidate for infliximab, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, which is approved in U.S., EU and other regions for the treatment of conditions including moderate to severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate to severe Crohn's disease, moderate to severe ulcerative colitis, psoriatic arthritis, ankylosing spondylitis. The active ingredient of ABP 710 is an anti-TNF monoclonal antibody that has the same amino acid sequence as infliximab. ABP 710 has the same pharmaceutical dosage form and strength as infliximab.
About Amgen Biosimilars
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