FDA approves Amjevita, biosimilar to Humira
The FDA has approved Amjevita, a biosimilar to Humira, according to an FDA press release.
“This is the fourth FDA-approved biosimilar,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions.”
Amjevita (adalimumab-atto, Amgen) is indicated for multiple inflammatory diseases in adults including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. In addition, it is indicated for polyarticular juvenile idiopathic arthritis for patients aged 4 years and older.
A biosimilar is a biological product that has been approved because it is highly similar to an already approved product and has no clinically meaningful differences in terms of safety and effectiveness.
The FDA’s approval is based on review of structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data and clinical immunogenicity data.
Like Humira (adalimumab, AbbVie), the box warning alerts health care workers that there is an increased risk for serious infections leading to hospitalization or death. In addition, lymphoma and other malignancies have been reported in children and adolescents treated with tumor necrosis factor blockers, including adalimumab products.
“[Amjevita] holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a company press release. “This milestone exemplifies our ongoing dedication to the development of high-quality biologic medicines.” – by Will Offit