FDA Accepts Application for Pfizer’s Biosimilar to Humira

FDA recently accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Pfizer’s interchangeable biosimilar to Humira, Abrilada.

Abrilada is a citrate-free biosimilar to Humira that received FDA approval in 2019 to treat certain patients with RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.

FDA based its PAS on positive topline data from the REFLECTIONS B538-12 study, which evaluated multiple switches between treatment with Abrilada and Humira. Researchers administered both drugs with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA).

The study met its primary goal of pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. Pfizer will submit study results for presentation in the near future.

“An interchangeability designation for Abrilada would help to support increased use of biosimilars by pharmacists and potentially lead to further cost savings,” Mike Gladstone, global president of inflammation & immunology at Pfizer, said in the recent announcement.

“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,” Gladstone continued.

Humira has been the top agent in global spending since 2012 and would have remained that way if not for the COVID-19 pandemic. In 2020, FDA-approved COVID-19 treatment, Veklury (remdesivir), replaced Humira in total spending across all classes of trade.

Biosimilars are newer, similar versions of complex medicines approved by the FDA as equivalent therapies. They play a vital role in treating autoimmune conditions and help increase patient access to essential medicines.

The current use of biosimilars saves the US healthcare system $240.4 million, while state Medicaid programs saved $47.5 million and commercial payers saved $136.8 million, according to a 2020 analysis.

Overall, US taxpayers and the healthcare sector may save nearly $7 billion annually with a more robust, more competitive biosimilars market, significantly increasingwhich significantly increases the current annual cost-savings of $240.4 million.