The regulator has approved the biosimilar based on the review of a comprehensive data package, demonstrating biosimilarity of ABRILADA to the reference product
Pfizer has secured the US Food and Drug Administration (FDA) approval for its ABRILADA (adalimumab-afzb), as a biosimilar to AbbVie’s Humira (adalimumab).
Adalimumab is a tumour necrosis factor (TNF) blocker that targets TNF to reduce inflammation and is used in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
Pfizer inflammation and immunology global president Richard Blackburn said: “Biosimilars like ABRILADA represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions.
“Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients.”
REFLECTIONS B538-02 trial is the basis for FDA approval of ABRILADA
The company said that the FDA has approved the biosimilar based on the review of a comprehensive data package, demonstrating biosimilarity of ABRILADA to the reference product.
The data includes results from the REFLECTIONS B538-02, a clinical comparative study which evaluated the efficacy, safety and immunogenicity of ABRILADA.
The study results showed no clinically meaningful differences in efficacy, safety or immunogenicity compared to the reference product, in patients with moderate to severe rheumatoid arthritis.
Infections, injection site reactions, headache, and rashes include the most common adverse reactions for adalimumab observed in the clinical trials.
Pfizer said that patients treated with adalimumab are found to be at increased risk for developing serious infections, potentially leading to hospitalization or death. Concomitant immunosuppressants including methotrexate or corticosteroids are prescribed to most patients who have developed the infections.
The infections reported in the studies include active tuberculosis (TB), invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis, in addition to the bacterial, viral, and other infections caused by opportunistic pathogens.
Pfizer said that it intends to launch its ABRILADA in 2023, subject to the terms of its agreement with AbbVie.