Samsung Bioepis and Organon have received interchangeability designation from the US Food and Drug Administration (FDA) for their Hadlima™ (adalimumab-bwwd) injection, 40 mg/0.4 ml and 40 mg/0.8 ml, making it interchangeable with all high* and low-concentration presentations of the reference product, Humira (adalimumab). This designation allows pharmacists to substitute the reference product with Hadlima without consulting the prescriber, subject to state pharmacy laws.
The interchangeability designation was based on clinical data from a randomized, double-blind, multiple-dose clinical trial, which demonstrated comparability in terms of pharmacokinetics, efficacy, safety, and immunogenicity profiles between the switching group and continuous Humira treatment group.
Hadlima is a tumor necrosis factor (TNF) blocker indicated for various conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
The high-concentration formulation of Hadlima was approved in 2022, and both low* and high-concentration formulations have been commercially available in the US market since 2023.
In a statement, Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon, highlighted the potential for increased patient access to biologic therapies and potential savings for the US healthcare system with the increased uptake of biosimilars. He also noted that patients paid more than four times as much out of pocket per month for Humira compared to Hadlima.
The press release also includes detailed safety information, emphasizing the risks associated with Hadlima, including serious infections, malignancies, hypersensitivity, hepatitis B virus reactivation, neurologic reactions, hematologic reactions, congestive heart failure, autoimmunity, and immunization considerations.
Samsung Bioepis, established in 2012, is a biopharmaceutical company committed to realizing accessible healthcare through innovations in product development and a commitment to quality. Today the company's shares have moved 6.66% to a price of $9.269. Check out the company's full 8-K submission here.
