AVSOLA is an anti-tumour necrosis factor alpha (anti-TNF) monoclonal antibody, which is very similar to Remicade and has no significant differences
Image: Amgen headquarters in Thousand Oaks, California, US . Photo: Courtesy of Coolcaesar/Wikipedia.
US-based biopharmaceutical firm Amgen has secured the US Food and Drug Administration (FDA) approval for AVSOLA (infliximab-axxq), its biosimilar to Remicade (infliximab).
Remicade, a chimeric monoclonal antibody biologic, is used as a medication for a variety of autoimmune diseases and is currently marketed by Janssen Biotech in the US, Mitsubishi Tanabe Pharma in Japan, Xian Janssen in China, and Schering-Plough, a part of Merck & Co. in another place.
Amgen global commercial operations executive vice president Murdo Gordon said: “The approval of AVSOLA represents an important milestone across our biosimilar and inflammation portfolios.
“Following July’s exciting launches of our two biosimilars in oncology, AVSOLA highlights Amgen’s long-term commitment to providing more affordable biological treatment options to patients across critical disease states, including chronic inflammatory conditions.”
FDA approved AVSOLA with similar indications of Remicade
Amgen said that its AVSOLA has been approved with similar indications of Remicade, for the treatment of rheumatoid arthritis (RA), chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS), along with moderate-to-severe ulcerative colitis (UC) and Crohn’s Disease (CD) in adults and infants.
In addition, according to comparative analytical, nonclinical and clinical data, its anti-tumour necrosis factor alpha (anti-TNF) monoclonal antibody AVSOLA, is very similar to Remicade, and has no significant differences.
The data include results from a randomized, double-blind, comparative clinical study that evaluated the safety and efficacy of AVSOLA, compared to Remicade, in 558 patients with moderate-to-severe RA.
The primary endpoint of the study was a 20% response difference (RD) improvement in American College of Rheumatology core set measurements (ACR20), and the secondary endpoints include DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at weeks 2, 6, 14, 22, 30, 34, 38, 46 and 50.
The company said that the patients treated with infliximab products are at high risk for developing active tuberculosis (TB), Invasive fungal infections, along with bacterial, viral and other infections, which may cause hospitalisation or death.
Furthermore, patients who developed the infections were subjected to concomitant immunosuppressants including methotrexate or corticosteroids, and the drug must be discontinued if a patient is observed developing serious infection or sepsis.