Amgen announced that the US Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab). Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. Amjevita is Amgen's first biosimilar to receive regulatory approval.
"Approval of Amjevita is an exciting accomplishment as it marks a new chapter in Amgen's story of being a leader in biotechnology. In addition, Amjevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This milestone exemplifies our ongoing dedication to the development of high quality biologic medicines."
The approval of Amjevita was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, nonclinical, pharmacokinetic and clinical data, including results from two phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The phase 3 studies each met their primary endpoint showing clinical equivalence to adalimumab. Safety and immunogenicity of Amjevita were also comparable to adalimumab.
The company's biosimilar adalimumab is also undergoing review by the European Medicines Agency, following a regulatory application submitted in December 2015. Biosimilar adalimumab is one of nine programs included in Amgen's robust pipeline of biosimilars.
Amjevita is a biosimilar to adalimumab, an anti-TNF-a monoclonal antibody. The active ingredient of Amjevita is an anti-TNF-a monoclonal antibody that has the same amino acid sequence as, and is highly similar to, adalimumab. Amjevita will be delivered in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications.
Amjevita is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Amjevita is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.
Amjevita is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Amjevita is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Amjevita is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Amjevita is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
Amjevita is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Amjevita should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.