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Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab

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Additional Information

Additional Relevant Details During the meeting, Amgen will present a comprehensive data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical comparability to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.  
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Catalyst Date
Occurred on:
Jul 12, 2016
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Related Keywords Adalimumab, Abp 501, Bla, Humira, Inflammatory Disease