FDA accepts Pfizer's sBLA for Abrilada interchangeability

The US Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) submitted by pharma giant Pfizer (NYSE: PFE) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).

The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in fourth-quarter 2022, and Pfizer currently plans to launch Abrilada in the USA as early as July 2023 in accordance with the terms of its agreement with AbbVie (NYSE: ABBV), which last year generated revenues of $20.69 billion from the drug.

“An interchangeability designation for Abrilada would help to support increased use of biosimilars by pharmacists and potentially lead to further cost savings,” said Mike Gladstone, global president, Inflammation & Immunology, Pfizer, adding: “Today’s announcement builds on our commitment to broaden access to essential, high-quality and cost-effective treatment options for patients living with certain chronic inflammatory conditions.”