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Samsung Bioepis, Organon obtain FDA nod for Humira biosimilar

Organon is expected to launch Hadlima on or after July 1, 2023.

Samsung Bioepis and Organon have received permission from the Food and Drug Administration for the citrate-free, high-concentration (100 mg/ml) formulation of Hadlima (adalimumab-bwwd), a biosimilar of Humira.

Hadlima will be available in pre-filled syringe and autoinjector options.

The medication previously was approved by the FDA as a low-concentration (50 mg/ml) formulation in July 2019 and outside the United States that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018, the company said.

[Read more: Boehringer Ingelheim obtains FDA OK for interchangeable Humira biosimilar]

“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 at 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.”

“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 United States in 2023,” said Joe Azzinaro, vice president, global commercial lead biosimilars at Organon. “Today, adalimumab is the largest drug expense in the United States. We look forward to making our biosimilar available for those that rely on it to help manage their disease.”

[Read more: FDA approves Samsung Bioepsis Lucentis biosimilar]

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

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