FDA News

FDA approves Abrilada, fifth Humira biosimilar

The FDA has approved Abrilada, a biosimilar to Humira, making it the fifth biosimilar to the reference drug and 25th biosimilar overall to gain approval in the United States, according to an agency press release.

“Today’s approval is one of nine new biosimilar products the FDA has taken action on in 2019, bringing the overall total of biosimilar approvals to 25,” Sarah Yim, MD, acting director of the FDA’s office of therapeutic biologics and biosimilars, said in the release. “I’m pleased to see this progress and am confident that the market for these therapies will continue to grow.”

Abrilada (adalimumab-afzb, Pfizer), has been approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

The approval was based on a data package that included results from the REFLECTIONS study, which compared the efficacy, safety and immunogenicity of Abiralada with Humira (adalimumab, AbbVie) in patients with moderate to severe rheumatoid arthritis. The study found no clinically meaningful differences, according to a press release issued by Pfizer.

The company plans to launch the biosimilar in 2023.

“Biosimilars like Abrilada represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” Richard Blackburn, global president at Pfizer Inflammation and Immunology, said in the release. “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.”

Reference:

FDA.gov

Pfizer.com

Disclosures: Blackburn is employed by Pfizer.

The FDA has approved Abrilada, a biosimilar to Humira, making it the fifth biosimilar to the reference drug and 25th biosimilar overall to gain approval in the United States, according to an agency press release.

“Today’s approval is one of nine new biosimilar products the FDA has taken action on in 2019, bringing the overall total of biosimilar approvals to 25,” Sarah Yim, MD, acting director of the FDA’s office of therapeutic biologics and biosimilars, said in the release. “I’m pleased to see this progress and am confident that the market for these therapies will continue to grow.”

Abrilada (adalimumab-afzb, Pfizer), has been approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

The approval was based on a data package that included results from the REFLECTIONS study, which compared the efficacy, safety and immunogenicity of Abiralada with Humira (adalimumab, AbbVie) in patients with moderate to severe rheumatoid arthritis. The study found no clinically meaningful differences, according to a press release issued by Pfizer.

The company plans to launch the biosimilar in 2023.

“Biosimilars like Abrilada represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” Richard Blackburn, global president at Pfizer Inflammation and Immunology, said in the release. “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.”

Reference:

FDA.gov

Pfizer.com

Disclosures: Blackburn is employed by Pfizer.