Recent Adalimumab Biosimilar Developments

FDA grants interchangeable designation to Pfizer’s adalimumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). ABRILADA was originally approved by the FDA in November 2019. The new interchangeable designation was supported by data from Pfizer’s Phase 3 REFLECTIONS B538-12 study, and applies to all approved indications. Pfizer has not yet launched ABRILADA, but states that “it will be available later this year at two price points . . . Starting in late October 2023, ABRILADA will be available at a list price (Wholesale Acquisition Cost) 5% below the Humira list price,” and “[l]ater in 2023, ABRILADA will be available at a second list price 60% below the Humira list price.” ABRILADA is the second adalimumab biosimilar to receive interchangeable designation, behind Boehringer Ingelheim’s CYLTEZO.

Boehringer Ingelheim releases pricing for its adalimumab biosimilar– On October 2, 2023, Boehringer Ingelheim (BI) announced that its adalimumab biosimilar is now available at low wholesale acquisition cost, priced at an 81% discount to HUMIRA (adalimumab). BI’s adalimumab biosimilar was originally approved by the FDA in August 2017, and was granted interchangeable status by FDA in October 2021. BI launched the product, marketed as CYLTEZO, in July 2023 at a 5% discount to HUMIRA.

Celltrion’s adalimumab biosimilar receives FDA approval for new doses – On October 4, 2023, the FDA approved two more dose versions of Celltrion’s YUFLYMA (adalimumab-aaty), an 80 mg/0.8 ml dose and a 20 mg/0.2 ml dose. Celltrion received approval by the FDA in May 2023 for a 40 mg/0.4 ml dose, and launched the product in July 2023.