FDA Approves Pfizer's Adalimumab Biosimilar, Abrilada

The FDA has approved Pfizer’s adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira.

In a statement, Sarah Yim, MD, acting director of the FDA’s Office of Therapeutic Biologics and Biosimilars in the Center for Drug Evaluation and Research, said she is pleased to see the 25th biosimilar approved in the United States, and that she is confident that the market for these products will continue to grow.

The biosimilar was studied in a 78-week, double-blind, multicenter, randomized study comparing the proposed biosimilar with EU-licensed Humira in 597 biologic-naïve patients with rheumatoid arthritis, and 26-week results of the study have been published.¹

The study’s primary end point was the proportion of patients reaching the American College of Rheumatology’s criteria for 20% improvement (ACR20) at week 12, which the investigators say is a sensitive timepoint for assessment of the speed of response, as it represents the start of the plateau of the time-response curve for ACR20.

The 26-week period of initial treatment was completed by 286 patients in the biosimilar arm and 273 patients in the reference arm. In the biosimilar arm, 68.7% of patients achieved ACR20, as did 72.7% of patients in the reference arm; the treatment difference was −3.98%, which was contained within the prespecified equivalence margin of ±14%. ACR20, 50, and 70 rates were also similar through week 26 for both groups.

Despite the new FDA approval, Abrilada will not be free to launch in the US market until November 20, 2023, after Pfizer struck an agreement with Humira’s maker, AbbVie, to end patent litigation in 2018.

Abrilada joins multiple other approved but unlaunched biosimilar adalimumab products in the United States; also permitted to launch in 2023 on the basis of patent settlements are Hyrimoz (developed by Sandoz), Cyltezo (Boehringer Ingelheim), Hadlima (Samsung Bioepis), and Amjevita (Amgen).

Reference

1. Fleischmann RM, Alten R, Pileckyte M, et al. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018;20(1):178. doi: 10.1186/s13075-018-1676-y.