Hadlima, a biosimilar of Humira, will be launched next year to treat patients with certain chronic autoimmune diseases.
The FDA has approved a high-concentration (100 mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing AbbVie’s Humira (adalimumab). Hadlima was developed by South Korea-based Samsung Bioepis and will be commercialized by Organon. It will be available in pre-filled syringe and autoinjector options when it launches July 1, 2023. The FDA had approved Hadlima in a low-concentration (50 mg/mL) formulation in July 2019.
“With this approval, we now have both a low and high concentration adalimumab biosimilar approved by the FDA, marking an important step towards expanding treatment options for patients suffering from certain chronic, autoimmune diseases,” Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in a press release.
Outside the United States, the low concentration formulation of the biosimilar has been available since 2018. Hadlima is a tumor necrosis factor (TNF) blocker used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease and ankylosing spondylitis.
The FDA approval of high-concentration Hadlima was based on clinical data from a randomized, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the two formulations in healthy volunteers.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
Read More