Celltrion USA’s FDA-approved biosimilar adalimumab-aaty, has been added program to the Costco member prescription program. Adalimumab-aaty is a high-concentration (100mg/mL) and citrate-free ...
Please provide your email address to receive an email when new articles are posted on . The complete response letter cites facility issues in denying the biosimilar. The approval process had been on ...
The FDA has accepted the supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira, from Organon (NYSE:OGN) and Samsung ...
FDA approves Ocrevus for multiple sclerosis AVT02 is a proposed biosimilar to Humira® (adalimumab) with high concentration (100mg/mL) dosage forms. The Food and Drug Administration (FDA) has accepted ...
INCHEON, South Korea and JERSEY CITY, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the U.S. Food and Drug Administration (FDA) ...
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