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Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA® Biosimilar HADLIMA™ (adalimumab-bwwd)

Thursday, August 18, 2022

Samsung Bioepis Co., Ltd. and Organon & Co. today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. HADLIMA was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019 and outside the US that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018.1,2

“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,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader, Samsung Bioepis. “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,” she added.

“Based on our success commercializing our adalimumab 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 US in 2023,” said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, Organon. “Today, adalimumab is the largest drug expense in the US. We look forward to making our biosimilar available for those that rely on it to help manage their disease.”

The approval of citrate-free, high-concentration HADLIMA was 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 two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.3

HADLIMA is expected to be launched on or after July 1, 2023 by Organon.

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