Biosimilar nomenclature: Deadline August 2 for comments on FDA’s OMB information request

Meaningful suffix may be in for U.S. biologics, biosimilars



FDA Pushes Back Comment Period for Biosimilar Labeling

Just released: new deadline August?2 for information collection request it submitted to the White House Office of Management and Budget (OMB)



Additional Reading

FDA approves Inflectra, a biosimilar to Remicade

A Rocky Start for Biosimilar Inflectra?

FDA Approves INFLECTRA? (Biosimilar Infliximab), The First U.S. Biosimilar Monoclonal Antibody, For All Eligible Indications

Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States

FDA Information on Biosimilars

Biosimilar switching not suitable for all patients



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