FDA Designates Pfizer’s Abrilada® as Interchangeable Biosimilar to AbbVie’s Humira® (adalimumab)

Pfizer announced that the FDA has designated Abrilada® as the second interchangeable biosimilar to AbbVie’s Humira® (adalimumab), Following BI’s Cyltezo®.  The designation applies to all approved Abrilada® indications.  Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) was the first approved  interchangeable adalimumab biosimilar on 15 October 2021.

The FDA accepted Pfizer’s sBLA for interchangeability for its adalimimab biosimilar Abrilada® on 25 February 2022, with a BsUFA goal date in Q4 2022.