January 2, 2019 PR-M01-19-NI-002
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
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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CONTACT: Amgen, Thousand Oaks
Kelley Davenport, 202-585-9637 (media)
Kristen Davis, 805-447-3008 (media)
Arvind Sood, 805-447-1060 (investors)
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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.