The U.S. Food and Drug Administration (FDA) has designated the Hadlima (adalimumab-bwwd) high- and low-concentration (40mg/0.4mL, 40mg/0.8mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira (adalimumab).

These interchangeability designations follow the interchangeability designation received for the Hadlima low-concentration (40mg/0.8mL) prefilled syringe and single-dose vial in June 2024.

Hadlima is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Now Interchangeable with All Presentations

Hadlima is now interchangeable with all presentations of the reference product. An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, depending on state pharmacy laws.

“An increased uptake of biosimilars may lead to improved patient access to biologic therapies and potential savings for the US health care system. As a company dedicated to making medicines more accessible, HADLIMA, now designated as fully interchangeable with the reference product, has a greater potential to bring savings for patients. As our data shows, on average, patients paid more than four times as much out of pocket per month for Humira compared to HADLIMA,” says Jon Martin, U.S. Commercial Lead, Biosimilars and Established Brands at Organon, in a news release. “With this approval, pharmacies can substitute HADLIMA for the reference product Humira without consulting prescribers (subject to state law), which may facilitate increased access for patients to receive the medications they need.”

“This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no clinically meaningful differences in safety, purity, and potency compared to the reference product,” adds Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “With this designation, we continue to benefit patients, health care providers, and health care systems around the world.”