Organon and Samsung Bioepis Co., Ltd. announced on May 27, 2025, that the U.S. Food and Drug Administration (FDA) has designated HADLIMA (adalimumab-bwwd) high- and low-concentration autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira (adalimumab). This follows a previous interchangeability designation for the low-concentration prefilled syringe and single-dose vial in June 2024.
With these additional designations, HADLIMA is now interchangeable with all presentations of the reference product, Humira. An interchangeability designation allows pharmacists to substitute the reference product with the biosimilar without consulting the prescriber, subject to state pharmacy laws, which can improve patient access and potentially generate savings for the U.S. healthcare system.
HADLIMA is a tumor necrosis factor (TNF) blocker indicated for various conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and plaque psoriasis. This designation is expected to facilitate increased access for patients to receive this medication.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.