Jianzhi Qiangsheng heavy weight anti-inflammatory drug like Ke! Amgen avsola has been approved by the U.S. FDA, the 4th infliximab bio generic!

December 13, 2019 / BIOON / -- Amgen, a biotechnology giant, recently announced that the US Food and Drug Administration (FDA) has approved avsola (infliximab axxq, infliximab) for reference drug REMICADE (Chinese trade name: Leke, generic name: infliximab, infliximab) all approved indications: for treatment of moderate and severe categories Rheumatoid arthritis (RA), Crohn's disease (CD), ulcerative colitis (UC), plaque psoriasis (PSO), psoriatic arthritis (PSA) and ankylosing spondylitis (as) in adults and children REMICADE is a heavy-duty anti-inflammatory drug of Johnson & Johnson It is an anti-tumor necrosis factor (anti-TNF) monoclonal antibody drug, which has been listed in many countries around the world Avsola and REMICADE have the same amino acid sequence, the same dosage form and intensity FDA approved avsola based on comparative analysis, non clinical, and full evidence of clinical data Moderate to severe rheumatoid arthritis (RA) phase III clinical study data in patients confirmed that there was no clinically significant difference between avsola and REMICADE: in terms of efficacy, after 22 weeks of treatment, avsola and REMICADE achieved non inferiority in terms of the primary end point ACR20, in terms of the key secondary end point, the results of acr50, acr70 and ACR20 of the two drugs had the same trend, and the average change of das28-crp relative to the baseline was close to 0 (- 0.01[-0.20，0.17]）。 According to the FDA database of biosimilars, up to now, 26 biosimilars have been approved by the FDA, including 4 for Johnson REMICADE Currently, Amgen has a total of 10 biosimilars in its biosimilars assets, four of which have been approved by the United States and three by the European market "Avsola's approval marks an important milestone in our entire bio generic and inflammatory portfolio," said Murdo Gordon, Amgen's executive vice president of global business operations Following the launch of two biosimilars in oncology in July, avsola highlighted Amgen's long-term commitment to providing more affordable biotherapy solutions for critically ill patients, including chronic inflammation " Original source: FDA approvals Amgen's avsola Gamma (infliximab-axxq), For The Same Indications As Remicade® (infliximab)