FDA approves citrate-free, high concentration formulation of Humira biosimilar
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The FDA has approved a citrate-free, 100 mg/mL formulation of the Humira biosimilar Hadlima, according to a statement released by Samsung Bioepis and Organon.
“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 for Samsung Bioepis, said in the statement. “By leveraging our development expertise, manufacturing excellence and supply chain reliability, we will continue our work to ensure healthcare systems have more affordable treatment options available.”
The FDA previously approved a low-concentration, 50 mg/mL formulation of Hadlima (adalimumab-bwwd, Samsung Bioepis) in 2019 to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
According to the statement, the approval of the citrate-free, high-concentration version is based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability and immunogenicity of the 100 mg/mL 50 mg/mL formulation in healthy volunteers.
Hadlima is expected to be released to the U.S. market on or after July 1, 2023, by Organon. It will be available in pre-filled syringe and autoinjector options. The biosimilar has already been released in other markets globally under various brand names, with more than 5 million doses sold since 2018, according to the statement.
“Based on our success commercializing our adalimumab [Humira, AbbVie] biosimilar in other markets around the world, combined with our established presence in the biosimilar space, we are excited about the opportunity to launch Hadlima in the U.S. in 2023,” Joe Azzinaro, vice president of global commercial lead biosimilars for Organon, said in the statement. “Today, adalimumab is the largest drug expense in the U.S. We look forward to making our biosimilar available for those that rely on it to help manage their disease.”
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