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 ...

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 ...

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 ...

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) ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. Back to Healio Amgen recently announced it has submitted ...

Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates. Fujifilm ...

Fresenius SE & Co. KGaA (FRE.XE) said Monday that it has submitted a biosimilar marketing authorization application to the European Medicines Agency for adalimumab. This is the first biosimilar ...

SUZHOU, China, Nov. 13, 2018 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, ...

Its exclusivity is set to expire in the European Union in April 2018. But Samsung Bioepis earlier this year asked the U.K. High Court of Justice to nullify dozens of additional patents on Humira in a ...