Samsung Bioepis and Organon Score Citrate-Free, High-Concentration Dose Approval

On August 17, the Food and Drug Administration granted approval to partners’ Samsung Bioepis and Organon for its new formulation of Hadlima™. This adalimumab biosimilar is now approved for use in a citrate-free, high-concentration formulation, in addition to its low-concentration, non–citrate free version that was approved in July 2019.

In its press release, Samsung Bioepis’ Vice President and Regulatory Affairs Team Leader Byoungin Jung stated, “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.” She added, “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.

Organon will launch Hadlima in the US in early July 2023. At present, only Fresenius Kabi and Sandoz do not have a citrate-free version of their biosimilar at this time, although Fresenius, Alvotech, and Celltrion are still awaiting FDA approval on their original 351(k) applications. It is also important to note that for the manufacturers who have received approval for citrate-free versions, the approval is specific to its high- or low-dose formulation (i.e., the low-concentration version may have been approved as non—citrate free, but the high-concentration dose was not).

In Other Biosimilar News

Formycon AG announced that its ustekinumab biosimilar passed its Phase 3 test, with preliminary results demonstrating itself to be noninferior to the reference product Stelara® in patients with moderate-to-severe plaque psoriasis. This could put the product on pace for a 2024 launch, and to compete with Amgen’s and Celltrion’s candidates for first approved ustekinumab biosimilar.

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