Tagged as: FDA

FDA Issues Final Definition for “Biological Product”

The FDA recently issued a final rule regarding the definition of “biological product,” amending its previous definition.  The statutory definition of “biological product” included “protein (except any chemically synthesized polypeptide),” but this past December Congress removed the parenthetical excluding “any chemically synthesized polypeptide.”  Now, the FDA has announced that it…

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FDA Issues Draft Guidance On Biosimilar Licensure For Fewer Than All Conditions Licensed for Reference Product

The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”  In this guidance, the FDA addresses the following issues: Submission of an application seeking licensure of a proposed biosimilar or proposed interchangeable…

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FDA’s Draft Guidance on Promotional Labeling and Advertising Considerations

Earlier this week FDA issued a draft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance addresses the truthful and non-misleading manner in which data and information concerning reference or biosimilar products must be presented. The draft guidance does not address issues…

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FDA Approves Samsung Bioepis's HADLIMA (adalimumab-bwwd)

Earlier this week, the U.S. FDA approved Samsung Bioepis’s  HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HADLIMA is the fourth adalimumab biosimilar to receive approval in the U.S. According to…

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