FDA Approves Pfizer’s Abrilada, Biosimilar to Humira, for IBD and Other Inflammatory Disorders

FDA Approves Pfizer’s Abrilada, Biosimilar to Humira, for IBD and Other Inflammatory Disorders

Abrilada (adalimumab-afzb), a biosimilar to Humira (adalimumab), has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of seven inflammatory disorders, including adult Crohn’s disease and ulcerative colitis, two forms of inflammatory bowel disease (IBD).

Pfizer, which developed Abrilada, aims to have the therapy available to U.S. patients in 2023.

Abrilada was also approved for rheumatoid arthritispsoriatic arthritisplaque psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis.

Adalimumab is the active ingredient in both Abrilada and Humira. It helps reduce inflammation by targeting and blocking the pro-inflammatory tumor necrosis factor.

biosimilar is a biologic medical product (which means that it is made from living cells rather than by chemical production) that is very similar to and has no clinically meaningful differences from an existing FDA-approved reference product (in this case, Humira).

Over the last decade, biosimilars have emerged as a powerful tool for cost savings in healthcare systems as they introduce competition into the market.

“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, Pfizer’s global president of inflammation and immunology, said in a press 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,” he said.

The FDA’s decision to approve Abrilada was based on a comprehensive data package provided by Pfizer that demonstrated the biosimilarity of Abrilada to AbbVie’s Humira.

The package included data from the Phase 3 REFLECTIONS B538-02 (NCT02480153) clinical study which investigated the efficacy, safety, and ability to trigger an immune response (immunogenicity) of Abrilada compared with Humira, each in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis.

Results revealed no clinically meaningful differences in efficacy, safety, and immunogenicity between Abrilada and Humira.

Currently, Pfizer is trying to make Abrilada available to patients in the U.S. as soon as possible based on its agreement with AbbVie.

Full prescribing information is available here.

Abrilada is the fifth Humira biosimilar to gain FDA approval in the United States, following the approvals of Samsung Bioepis’ Hadlima earlier in 2019, Sandoz’s Hyrimoz in 2018, Boehringer Ingelheim’s Cyltezo in 2017, and Amgen’s Amjevita in 2016.