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Amgen Inc.

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Amgen has added a news release to its Investor Relations website.
Title: Amgen's First Biosimilar Marketing Authorization Application Submitted To European Medicines Agency For ABP 501

Supported By Phase 3 Studies in Moderate-to-Severe Plaque Psoriasis and Moderate-to-Severe Rheumatoid Arthritis
THOUSAND OAKS, Calif. , Dec. 4, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501, a biosimilar candidate to Humira® (adalimumab). Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the European Union .
"The submission of Amgen's first biosimilar application to the EMA is an exciting milestone as we seek to expand our global patient reach," 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 medicines to patients worldwide."
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-a monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.
Amgen's MAA 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 in both studies. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.
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Source: press release, 12/04/15. http://wwwext.amgen.com/media/news-releases/

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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 EMA: CHMP Opinion (Estimate)

Dates: 2016-12-16

Results:

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Amgen Receives Positive CHMP Opinion For ABP 501 (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases
First Adalimumab Biosimilar Candidate Recommended for EMA Approval
THOUSAND OAKS, Calif., Jan. 27, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 501 (biosimilar adalimumab), recommending approval for all available indications. ABP 501 has been recommended for approval for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. The CHMP opinion also recommends approval for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn's disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).

"The positive CHMP opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases."

The Marketing Authorization Application (MAA) submission for ABP 501 was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, 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 no clinically meaningful differences to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 were also included in the submission.

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.

ABP 501 was approved in the United States (U.S.) by the U.S. Food and Drug Administration (FDA) on Sept. 23, 2016, where it goes by the brand name AMJEVITA™ (adalimumab-atto).
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Source: press release, 1/27/17. http://wwwext.amgen.com/media/news-releases/2017/01/amgen-receives-posit...

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