Samsung Bioepis and Organon announced that the US FDA has accepted for review their Supplemental Biologics License Application (sBLA) seeking interchangeability designation for Hadlima™ (adalimumab-bwwd) injection 40 mg/0.4 mL, biosimilar to Humira® (adalimumab). The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.
Samsung Bioepis and Organon announced the interchangeability results for Hadlima™ in August .
The FDA has designated both Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) and Pfizer’s Abrilada® as interchangeable biosimilars to Humira®. The FDA has accepted Alvotech’s BLA for AVT02, its high concentration, interchangeable biosimilar, with a goal date of 24 February 2024. Celltrion is also seeking an interchangeability designation for its approved biosimilar Yuflyma®, which it reported is tentatively expected in Q4 2024.