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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
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
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 have an inadequate response to methotrexate (MTX). The study consisted of a screening period of four weeks and a treatment period of 22 weeks, followed by a safety follow-up period through to week 26. There were 526 patients enrolled. Among them, there were 264 patients randomized to receive ABP 501 40 mg subcutaneous (SC) every two weeks and 262 patients randomized to receive adalimumab 40 mg SC every two weeks. The primary endpoint was assessment of ACR20 at week 24.
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic inflammatory disease of unknown etiology in which patients exhibit sytemic features such as fatigue, low grade fever, weight loss, anemia and increased systemic levels of acute phase reactants (e.g., erythrocyte sedimentation rates [ESR] and C-reactive protein [CRP]).1
About ABP 501
ABP 501 is being developed as a biosimilar candidate for adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several 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
For more information, visit www.amgenbiosimilars.com.
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 one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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1. Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO III, et al. 2010 rheumatoid arthritis classification criteria: an
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