Filing for ABP 710, a Biosimilar Candidate to Infliximab, Supported by Phase 3 Study in Patients With Moderate-to-Severe Rheumatoid Arthritis
THOUSAND OAKS, Calif./PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE® (infliximab).
"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 David M. Reese, M.D., executive vice president of Research and Development at Amgen. "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."
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.
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 (EU).
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
Amgen Biosimilars is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars will help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.
Forward Looking Statements
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CONTACT: Amgen, Thousand Oaks
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