As Remdantry uses the same Drug Identification Number (DIN) as Inflectra ®, the formulation, indications and dosages of Remdantry will remain the same as that of Inflectra, which was originally ...

Celltrion, Inc., a leading global biopharmaceutical company, announced today that its infliximab biosimilar will be marketed in Canada under the new b ...

CT-P13, intravenous infliximab, developed and manufactured by Celltrion, is the first monoclonal antibody biosimilar therapy and has been the most established biosimilar treatment in the Canadian ...

positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027. Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for ...

“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...

A biosimilar is a biological product that is approved based on data demonstrating that the product is highly similar, with no clinically meaningful differences, to a Food and Drug Administration ...

Biosimilars provide a cost-effective alternative to expensive branded biologics, increasing accessibility for patients while driving competition among manufacturers. Technological Advancements in ...

Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have ...

J&J seeks preliminary injunction over Samsung's sublicense deal with private label provider J&J says said sublicense deal would hurt its market share Samsung Bioepis launched its biosimilar in U.S ...