Pfizer has received approval from the US Food and Drug Administration (FDA) for Abrilada, a biosimilar to AbbVie’s Humira (adalimumab).
Abrilada is designed to inhibit tumour necrosis factor (TNF). The medication can be used to treat patients with Crohn’s disease, plaque psoriasis, ankylosing spondylitis, juvenile idiopathic arthritis, ulcerative colitis, rheumatoid arthritis and psoriatic arthritis.
FDA approval comes from a comprehensive data package, which showed biosimilarity of Pfizer’s product to the reference product, Humira.
In the REFLECTIONS B538-02 comparative study, Abrilada did not show any clinically meaningful differences in safety, efficacy or immunogenicity when compared to Humira.
The study assessed the medication in combination with methotrexate in patients suffering from moderate to severe rheumatoid arthritis.
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.”
Adalimumab blocks TNF to help reduce inflammation. AbbVie’s European patent for Humira has already expired and the US patent is set to expire in 2023.
In December last year, Pfizer signed licensing agreements with AbbVie to use and sell its biosimilar of Humira. Under the deal, the US licence period will begin on 20 November 2023.
Pfizer is making preparations to launch Abrilada according to the agreement terms.
Earlier this month, Chinese pharmaceutical company Bio-Thera Solutions secured regulatory approval for Qletli, also a biosimilar to Humira, for all available indications of the reference product.
Qletli, an anti-TNF- α monoclonal antibody, is the first Humira biosimilar approved in China.