FDA Approves Amgen’s Amjevita, a Humira BiosimilarBy
Amgen has received approval from the US Food and Drug Administration (FDA) for Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab), AbbVie’s anti tumor necrosis factor (TNF) monoclonal antibody that is approved for multiple indications. Amjevita, a biosimilar to Humira, 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.
Humira is AbbVie’s leading product, with global net sales of $14 billion in 2015.
Amgen’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 pipeline of biosimilars.
In the US, Amjevita is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (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.
It is also indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older; and 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.
Other indications for Amjevita include: reducing signs and symptoms in adult patients with active ankylosing spondylitis; 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; inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants; and treating 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.