Pfizer's Biosimilar Abrilada (adalimumab-afzb) Receives FDA Approval for Multiple Autoimmune Diseases

VCBeat (WeChat ID: vcbeat) learned from foreign media that on November 18, 2019, local time, pharmaceutical giant Pfizer announced that its biosimilar Abrilada (adalimumab-afzb) had received FDA approval for market launch, for the treatment of various autoimmune diseases.

It is understood that Abrilada is a biosimilar developed by Pfizer targeting Humira (adalimumab), the flagship product of pharmaceutical giant AbbVie. Its indications include rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn's disease (CD), ulcerative colitis (UC), and plaque psoriasis.

The FDA’s approval was based on a review of a comprehensive data package demonstrating the biosimilarity between Abrilada and Humira, which included results from the REFLECTIONS B538-02 comparative clinical study. This randomized, double-blind, parallel-group Phase III clinical study showed no clinically meaningful differences between Abrilada and Humira in terms of efficacy, safety, and immunogenicity.

Richard Blackburn, President of Pfizer’s Inflammation and Immunology division, stated that biosimilars such as Abrilada enable more patients with chronic diseases to access treatment. “We currently have one of the largest portfolios of approved biosimilar products in the industry, and we are honored to provide patients with more treatment options.”

It is reported that Abrilada is the ninth biosimilar approved by the FDA in 2019 and the fifth Humira biosimilar approved by the agency to date. In addition to Abrilada, developed by Pfizer, the other four approved Humira biosimilars are:

The Other Four FDA-Approved Humira Biosimilars

Humira, as AbbVie's flagship product, is the world's first approved anti-tumor necrosis factor-alpha (TNF-α) drug. It is also the best-selling anti-inflammatory drug globally, with global sales reaching $19.936 billion in 2018, including a net revenue of $13.685 billion from the U.S. market.

Pfizer stated that it is establishing distribution channels for its own Abrilada in accordance with the terms of the agreement reached with AbbVie, so as to launch the product on the market after the patent rights for Humira expire in 2023.

(Compiled by Hu Lushuang)