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Alvotech/Teva’s BLAs for Biosimilar Golimumab First to be Accepted by FDA
On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® and Simponi Aria® (golimumab), which are indicated for a variety of...