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A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Enrollment: 526
Study Start Date: October 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT01970475?term=ABP-501&phase=2&ran...

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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: III

Event Type: Data: Phase III trial results

Dates: 2015-04-01 - 2015-09-30

Results:

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Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab
First Completed Phase 3 Study of Adalimumab Biosimilar in the Treatment of Patients With Moderate-to-Severe Rheumatoid Arthritis
THOUSAND OAKS, Calif., Nov. 9, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today presented detailed findings from a head-to-head Phase 3 study comparing the safety, efficacy and immunogenicity of biosimilar candidate ABP 501 with adalimumab in patients with moderate-to-severe rheumatoid arthritis. The results were presented today in an oral presentation at the 2015 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Francisco.

The study met the primary endpoint, which was achievement of ACR20 (20 percent or greater improvement in ACR assessment) at week 24. At week 24, 74.6 percent of patients in the ABP 501 group and 72.4 percent in the adalimumab group met the ACR20 response criteria. The risk ratio of ACR20 was 1.039 with the two-sided 90 percent CI of 0.954–1.133, which fell within the predefined equivalence margin.

"Demonstrating biosimilarity is scientifically complex, but Amgen's 35 years of proven biologic R&D experience is facilitating the advancement of exciting programs like ABP 501," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Our long-term commitment to advancing care in inflammation is as strong as ever, with a portfolio of novel and biosimilar compounds that have the potential to benefit patients worldwide."

ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe plaque psoriasis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.

Secondary endpoints included the achievement of ACR50 and ACR70 (a 50 or 70 percent improvement in ACR assessment) within the predefined equivalence margin. At week 24, patients treated with ABP 501 compared with those treated with adalimumab achieved ACR50 (49.2 percent vs. 52.0 percent) and ACR70 (26.0 percent vs. 22.9 percent), respectively. Additionally, the secondary endpoint of a difference in change from baseline of DAS28-CRP (Disease Activity Score examines 28 joints in the body as measured by C reactive protein in the blood) over the entire study was also achieved. The difference in mean change from baseline in DAS28-CRP between ABP 501 and adalimumab was –0.01 (90 percent CI, –0.18 to 0.17) at week 24.

The incidence of treatment-emergent adverse events (TEAEs) was 50 percent for ABP 501 and 55 percent for adalimumab. The most frequently reported TEAEs (for ABP 501 and adalimumab, respectively) were nasopharyngitis (6.4 percent vs. 7.3 percent), headache (4.5 percent vs. 4.2 percent), arthralgia (3.0 percent vs. 3.4 percent), cough (2.7 percent vs. 3.1 percent) and upper respiratory tract infection (1.5 percent vs. 3.8 percent). Serious adverse events (3.8 percent vs. 5.0 percent) and serious infections (0.8 percent vs. 1.1 percent) were reported in patients treated with ABP 501 and adalimumab, respectively. By the end of week 24, binding antibodies (38.3 percent vs. 38.2 percent) and neutralizing antibodies were identified (9.1 percent vs. 11.1 percent) in patients treated with ABP 501 and adalimumab, respectively.

Study Design
This randomized, double-blind, active-controlled study (study number 20120262) evaluated safety, efficacy and immunogenicity of ABP 501 compared to adalimumab in adult patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate. The study consisted of a screening period of four weeks and a treatment period of 22 weeks. Patients were randomized to receive either 40 mg ABP 501 subcutaneous injection (SC) every two weeks (n=264) or 40 mg SC adalimumab every two weeks (n=262) until week 22. The study completed at week 24, followed by a safety follow-up period through to week 26.
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Source: press release, 11/09/15. http://wwwext.amgen.com/media/news-releases/2015/11/amgen-presents-detai...

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Feb. 3, 2015
Amgen Announces Positive Top-Line Results From Phase 3 Study Evaluating The Efficacy And Safety Of Biosimilar Candidate ABP 501 Compared With Adalimumab In Patients With Moderate-To-Severe Rheumatoid Arthritis
Primary Efficacy Analysis Demonstrates Clinical Equivalence
Second Positive Phase 3 Study for Amgen's ABP 501
THOUSAND OAKS, Calif., Feb. 3, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira® (adalimumab) in patients with moderate-to-severe rheumatoid arthritis met its primary and key secondary endpoints. The primary endpoint compared the ACR20 measurements (20 percent or greater improvement in ACR assessment) at week 24. The ACR20 was within the prespecified margin for ABP 501 compared to adalimumab, showing clinical equivalence. Safety and immunogenicity of ABP 501 were comparable to adalimumab. Key secondary endpoints included ACR50, ACR70 and DAS 28-CRP.

ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis.

"The positive results from Amgen's biosimilar Phase 3 rheumatoid arthritis study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to adalimumab. Amgen's success on both our ABP 501 psoriasis and rheumatoid arthritis studies underscores our expertise in the research and development of high-quality biologic therapies," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Inflammation remains a core therapeutic area for Amgen, and we are committed to leveraging our long-term heritage in the space to deliver a portfolio of biosimilar and novel compounds that benefit patients worldwide."

Amgen has nine biosimilar molecules in development and expects to launch five of these biosimilars between 2017 and 2019.
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Source: press release, 2/03/15. http://wwwext.amgen.com//media/media_pr_detail.jsp?year=2015&releaseID=2...

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