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Amgen's First Biosimilar Biologics License Application For ABP 501 Submitted To U.S. Food And Drug Administration

Supported by Phase 3 Studies in Moderate-to-Severe Plaque Psoriasis and Moderate-to-Severe Rheumatoid Arthritis

THOUSAND OAKS, Calif., Nov. 25, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) with the United States (U.S.) Food and Drug Administration (FDA) for ABP 501, a biosimilar candidate to Humira® (adalimumab). Amgen believes this submission is the first adalimumab biosimilar application submitted to the FDA and represents Amgen's first BLA submission using the 351(k) biosimilar pathway.

"The submission of Amgen's first biosimilar application to the FDA is an exciting milestone, expanding our inflammation portfolio to provide additional therapeutic options to patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen's branded biologic medicines and biosimilars are developed and manufactured according to the same high standards, and we are committed to delivering high-quality medicines to patients with serious inflammatory diseases."

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.

Amgen's BLA submission includes analytical, clinical and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

About ABP 501
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

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 offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.
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Source: press release, 11/25/15. http://wwwext.amgen.com/media/news-releases/2015/11/amgens-first-biosimi...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
ABP 501 (Humira) (adalimumab) BiosimilarAutoimmune DiseaseInflamatory diseaseanti-TNF-α monoclonal antibodyTNF-α

Mechanism of action: ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

Phase of Development: Filed

Event Type: Regulatory FDA: BsUFA DATE

Dates: 2016-09-25

Results:

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FDA Approves Amgen's AMJEVITA™ (Adalimumab-Atto) For Treatment Of Seven Inflammatory Diseases
First Regulatory Approval for Company's Biosimilar Portfolio
First Biosimilar Adalimumab Approved by FDA
THOUSAND OAKS, Calif., Sept. 23, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. AMJEVITA is Amgen's first biosimilar to receive regulatory approval.

"Approval of AMJEVITA is an exciting accomplishment as it marks a new chapter in Amgen's story of being a leader in biotechnology. In addition, AMJEVITA holds the potential to offer patients with chronic inflammatory diseases an additional treatment option," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This milestone exemplifies our ongoing dedication to the development of high quality biologic medicines."

The approval of AMJEVITA was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, nonclinical, pharmacokinetic and clinical data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase 3 studies each met their primary endpoint showing clinical equivalence to adalimumab. Safety and immunogenicity of AMJEVITA were also comparable to adalimumab.

The Company's biosimilar adalimumab is also undergoing review by the European Medicines Agency, following a regulatory application submitted in December 2015. Biosimilar adalimumab is one of nine programs included in Amgen's robust pipeline of biosimilars.
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Source: press release, 9/23/16. http://wwwext.amgen.com/media/news-releases/2016/09/fda-approves-amgens-...

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