Amgen intros Humira biosimilar
Amgen is introducing Amjevita (adalimumab-atto), a biosimilar to AbbVie’s Humira. Amjevita was the first biosimilar to Humira approved by the Food and Drug Administration in 2016.
"With today's announcement, Amjevita is the first U.S. biosimilar to Humira, a medicine used by more than a million patients living with certain serious inflammatory diseases," said Murdo Gordon, executive vice president of global commercial operations at Amgen. "With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply this biosimilar medicine while reducing costs."
"Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the healthcare system," said Steven Taylor, president and CEO at the Arthritis Foundation. "Amjeviat provides another treatment option for patients and their doctors."
[Read more: Fresenius Kabi receives FDA approval for Humira biosimilar]
Amjevita (40 mg) is available at a list price (Wholesale Acquisition Cost) 55% below the current Humira list price. Amjevita also is available at a list price 5% below the current Humira list price. Amgen's goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers, the company said.
Like Humira's citrate-free formulation that is associated with less pain at the injection site, Amjevita is citrate-free. It will be available in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications.
Amjevita is an anti-TNF-α monoclonal antibody.
It is indicated 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, alone or in combination with methotrexate or other non-biologic DMARDs; and reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, alone or in combination with methotrexate.
[Read more: Samsung Bioepis, Organon obtain FDA nod for Humira biosimilar]
It also is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis, alone or in combination with non-biologic DMARDs; reducing signs and symptoms in adult patients with active ankylosing spondylitis; the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older; and the treatment of moderately to severely active ulcerative colitis in adult patients.