FDA OKs Ninth Humira Biosimilar, With Interchangeability

The US Food and Drug Administration (FDA) has granted an interchangeability designation to adalimumab-afzb (Abrilada), according to an announcement from Pfizer.

This is the second adalimumab biosimilar granted interchangeability. The first, adalimumab-adbm (Cyltezo), became available in July.

Biosimilars introduce market competition that can help lower drug prices. Adalimumab-afzb is one of nine approved biosimilars for Humira, and the last to launch in 2023.

Adalimumab-afzb is indicated for:

  • Adults with rheumatoid arthritis (RA)

  • Polyarticular juvenile idiopathic arthritis in patients 2 years of age and older

  • Adults with psoriatic arthritis

  • Adults with ankylosing spondylitis

  • Crohn disease’s in adults and children 6 years of age and older

  • Adults with ulcerative colitis

  • Adults with plaque psoriasis

  • Adults with hidradenitis suppurativa

  • Adults with noninfectious intermediate and posterior uveitis and panuveitis

“With this designation, Abrilada is now both biosimilar to and interchangeable with Humira, reinforcing confidence among physicians and pharmacists that there is no decrease in effectiveness or increase in safety risk associated with switching between Abrilada and the reference product,” Roy Fleischmann, MD, clinical professor of medicine, University of Texas Southwestern Medical Center, Dallas, said in Pfizer’s statement.

An interchangeability designation allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). To achieve this designation, Pfizer submitted data from a phase 3 study led by Fleischmann that evaluated adalimumab-afzb in patients with RA. Patients who were switched three times between the biosimilar and the reference product had outcomes similar to patients continuously treated with the reference product. 

Adalimumab-afzb will be available later this month at a 5% discount from Humira’s price. Later this year, the drug will launch at a second price, a 60% discount from Humira.

Full prescribing information for adalimumab-afzb is available here.

Source: Read Full Article