Adalimumab-adaz HCF receives U.S. FDA approval

The U.S. Food and Drug Administration (FDA) has granted approval to biosimilar adalimumab-adaz high concentration formula (HCF).¹

Adalimumab-adaz has been approved for seven indications, aligned with its reference drug adalimumab, including psoriatic arthritis and plaque psoriasis.¹

Adalimumab, the active component in adalimumab-adaz, is an inhibitor of tumor necrosis factor (TNF), which is commonly overproduced in autoimmune disorders such as psoriatic arthritis and plaque psoriasis. The overproduction of TNF can result in symptoms such as joint, skin, and mucosal inflammation.¹

The U.S. FDA have approved adalimumab-adaz following the results of the phase I pharmacokinetics bridging study which compared adalimumab (50 mg/mL) with adalimumab-adaz (100 mg/mL). The trial met all primary endpoints and adalimumab-adaz was found to have comparable safety, pharmacokinetics, and immunogenicity.¹