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Pfizer's Humira biosimilar secures FDA approval, due to launch in 2023

Published on 18/11/19 at 12:54pm

Pfizer has confirmed the FDA approval of Abrilada (adalimumab-afzb),  its biosimilar version of AbbVie’s Humira, the world’s best-selling drug,  

Pfizer’s therapy is now authorised for use in all approved indications of its reference product, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

“Comprehensive” data submitted in support of the decision showed that Abrilada demonstrated adequate biosimilarity to Humira, including no meaningful differences in terms of safety, efficacy or immunogenicity in moderate to severe rheumatoid arthritis.

“Biosimilars like Abrilada represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” remarked Richard Blackburn, Global President, Pfizer Inflammation and Immunology. “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.”

Pfizer confirmed that the intended launch date of the drug in the US is set for 2023.

Matt Fellows

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