Pfizer Receives Interchangeable Designation of Abrilada, a Biosimilar to Humira from the US FDA
Shots:
- Abrilada (adalimumab-afzb), a biosimilar to Humira (adalimumab) had received an interchangeable designation from the US FDA. The designation applies to all its approved indications, incl. RA, JIA, PsA, AS, CD, UC, PsO, hidradenitis suppurativa and uveitis
- The designation was based on the P-III study (REFLECTIONS B538-12) results published in The Lancet Rheumatology demonstrated similar patient outcomes in terms of PK, safety, and immunogenicity in patients with active RA who switched multiple times b/w Abrilada and Humira
- ABRILADA will be available at a list price 5% lower than that of Humira with a second list price 60% lower than that of Humira anticipated later in 2023
Ref: Pfizer | Image: Pfizer
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