FDA approves citrate-free, high concentration formulation of Humira biosimilar

August 24, 2022

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 andRead More

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