FDA Defers Action on Humira Biosimilar

FDA has told Reykjavik, Iceland-based Alvotech that it is deferring action on its BLA for AVT02, the company’s proposed biosimilar of AbbVie’s Humira (adalimumab) Humira, until manufacturing facility inspections/assessments can be completed. “The FDA can defer action when no deficiencies have been identified and the application otherwise satisfies the requirements for approval, but an inspection(s) is necessary yet cannot be completed due to factors including travel restrictions,” the company says.

Humira is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis (four years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. Alvotech says it is the only company that has both submitted a BLA for a proposed Humira biosimilar and conducted a switching study in support of an FDA designation for interchangeability (pharmacy substitution).