Pfizer Gains FDA Approval for Humira Biosimilar

November 18, 2019

Expected U.S. launch in 2023.

The FDA has approved adalimumab-afzb (Abrilada), Pfizer’s tumor necrosis factor biosimilar to Humira (AbbVie) for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

“Biosimilars like ABRILADA represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” said Richard Blackburn, global president of Pfizer’s Inflammation and Immunology in a statement. “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.”

The approval is based upon results from the REFELCTIONS B538-02 trial that evaluated the safety, efficacy, and immunogenicity of adalimumab-afzb compared to reference product tin 597 patients. 

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Pfizer says that no clinically meaningful differences were observed in patients with moderate to severe rheumatoid arthritis who were also taking methotrexate. 

Warnings and precautions issued with the use of adalimumab-afzb include the development of serious infections, invasive fungal infections, malignancies, anaphylaxis or serious allergic reactions, Hepatitis B virus reactivation, demyelinating disease, cytopenias and pancytopenia, heart failure, and lupus-like syndrome. 

Adverse reactions reported with the use of adalimumab-afzb include infections (particularly upper respiratory and sinusitis), injection site reactions, headache, and rash. 

As of now, Pfizer says they are anticipating a U.S. launch in 2023, pending further updates regarding an agreement with AbbVie. 

This is the fifth Humira biosimilar approved by the FDA. Previous biosimilars include HADLIMA (adalimumab-bwwd, Merck,) Hyrimoz (adalimumab-adaz, Sandoz), Cyltezo (adalimumab-adbm, Boehringer Ingelheim), and Amjevita (adalimumab-atto, Amgen). All were delayed to market in the U.S. due to ongoing litigation.

 

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