FDA Approval of Respiratory Biosimilars—Turning the Tide of Cost‐Effectiveness?

Abstract In March 2025, the Food and Drug Administration (FDA) approved the first respiratory biosimilar: omalizumab‐igec. FDA designated omalizumab‐igec as “interchangeable” with the anti‐IgE antibody omalizumab, which will permit pharmacists to perform substitution without consulting providers. This biosimilar will compete with blockbuster biologics indicated for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) and other inflammatory airway diseases. Biologics are presently not cost‐effective for CRSwNP and should be reserved for patients who have not responded to conventional therapy (eg, nasal steroids and endoscopic sinus surgery) or are unfit for surgery. However, market entry of omalizumab‐igec and other omalizumab biosimilars in late‐stage clinical development may spur substantial price reductions if biosimilar manufacturers are able to overcome barriers such as patient and physician skepticism and restrictive state pharmacy laws (eg, requiring patient consent for biosimilar substitution). Comparative cost‐effectiveness research is necessary to inform coverage policies and treatment decisions by patients and clinicians.