Alvotech Inspection Findings Hold Up Humira Biosimilar

FDA has issued Alvotech a complete response letter on its biosimilar BLA for AVT02, a monoclonal antibody that was being evaluated for biosimilarity and interchangeability to Abbott’s Humira (adalimumab). The letter cited inspection deficiencies at its Reykjavik, Iceland manufacturing facility, which must be corrected before the therapy can be approved, according to the company.

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 has said 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).

Alvotech says AVT02 has been approved in the European Union, Norway, Iceland, Lichtenstein, the United Kingdom, Switzerland, and Canada.