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Ph III study of Amgen’s Humira biosimilar ABP 501 meets endpoint in psoriasis

Ph III study of Amgen's Humira biosimilar ABP 501 meets endpoint in psoriasis 1

Second Positive Phase 3 Study for Amgen’s ABP 501 THOUSAND OAKS, Calif. 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. 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. 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. US biotech major Amgen says its Phase III study evaluating the efficacy and safety of its biosimilar candidate ABP 501 compared with AbbVie s blockbuster drug H. Ph III study of Amgen’s Humira biosimilar ABP 501 meets endpoint in psoriasis. Phase III study of biosimilar adalimumab meets primary endpoint. III trial of Amgen’s adalimumab biosimilar (ABP 501) compared with Humira (adalimumab) has demonstrated clinical equivalence’. ABP 501 and Humira in subjects with moderate to severe plaque psoriasis with respect to the per cent improvement in Psoriasis Area and Severity Index (PASI) after treatment.

Ph III study of Amgen's Humira biosimilar ABP 501 meets endpoint in psoriasis 2Amgen said Wednesday that its biosimilar candidate ABP 501 met the primary endpoint of equivalence to AbbVie’s Humira (adalimumab) in a Phase III study of patients with moderate-to-severe plaque psoriasis. Amgen said Wednesday that its biosimilar candidate ABP 501 met the primary endpoint of equivalence to AbbVie’s Humira (adalimumab) in a Phase III study of patients with moderate-to-severe plaque psoriasis. Phase3 Plaque Psoriasis Study Met Primary Endpoint For Efficacy – (NASDAQ). Amgen reports that a Phase 3 study of ABP 501 in the treatment of moderate-to-severe plaque psoriasis (PsO) has met its primary endpoint. Amgen’s Biosimilar Candidate Meets Primary Endpoint In Phase 3 Psoriasis Trial. The trial compared ABP 501 to Humira (adalimumab), showing equivalency in the Psoriasis Area and Severity Index (PASI), immunogenicity, and safety. 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. The safety and immunogenicity of ABP 501 were comparable to adalimumab and the trial’s major secondary endpoints included ACR50, ACR70 and DAS 28-CRP. Amgen executive vice-president of Research and Development Sean Harper said: The positive results from Amgen’s biosimilar Phase III rheumatoid arthritis study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to adalimumab.

The primary endpoint, PASI percent improvement, was evaluated at week 16. Amgen has presented detailed findings from a head-to-head Phase III study comparing the safety, efficacy and immunogenicity of ABP 501 (adalimumab-biosimilar) with Humira (adalimumab) in patients with. ABP 501 showed clinical equivalence to adalimumab in studies. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

Amgen’s Humira Biosimilar Hits Main Goal Of Phase Iii Study In Psoriasis

Amgen announced that its Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared to Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint. Second Positive Phase 3 Study for Amgen’s ABP 501. 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. 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. The primary endpoint, PASI percent improvement, was evaluated at week 16. Oncobiologics’ Humira Biosimilar Candidate Meets Main Goal in Study. (adalimumab) biosimilar candidate met its primary endpoint in its first clinical study. The company said that in a Phase III study its biosimilar candidate ABP 501 has shown equivalence in safety and effectiveness with AbbVie’s Humira (adalimumab), and has met its primary and key secondary endpoints. 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. Baxalta is also developing a biosimilar version of Amgen’s (AMGN – Analyst Report) Enbrel for the treatment of rheumatoid arthritis and psoriasis. Onconova Starts Phase III INSPIRE Study on Rigosertib in EU. This current study will continue for 52 weeks. It’s the second Phase 3 trial of CHS-0214, which is manufactured by Baxalta. In November 2015, CHS-0214 met its primary endpoints for the treatment of patients with chronic plaque psoriasis.

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Amgen indicated that its Phase 3 studies met their primary endpoints showing clinical equivalence to Humira. The safety and immunogenicity of ABP 501 was also comparable to Humira. Renflexis was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. Highly similar with fingerprint-like similarity: Under this assessment, the proposed biosimilar product meets the statutory standard for analytical similarity based on integrated, multi-parameter approaches that are extremely sensitive in identifying analytical differences. Study results showed ACR 20 for ABP 501 was within the prescribed margin compared with adalimumab. Amgen Phase 3 study of biosimilar candidate ABP 501 met primary endpoint. The study met the primary endpoint, which was achievement of ACR20 at week 24. 6 percent of patients in the ABP 501 group and 72.4 percent in the adalimumab group met the ACR20 response criteria. ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-alpha 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.