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USFDA Draft Guidance: Biosimilar and Interchangeable Biosimilar Products – Considerations for Container Closure Systems and Device Constituent Parts
As biosimilar development continues to advance, regulatory expectations extend well beyond demonstrating analytical similarity and clinical performance. Product presentation—including the container closure system (CCS) and device constituent parts—has become an important aspect of ensuring product quality, usability, and patient safety throughout the product lifecycle. The U.S. Food and Drug Administration (FDA) has published the draft guidance Biosimilar and Interchangeable
Sharan Murugan
Aug 23 min read
USFDA Q&A: Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products
As biosimilars and interchangeable biosimilars become an integral part of modern biologic therapy, promotional communications around these products require heightened regulatory care. To address recurring industry questions and reduce the risk of misleading claims, the FDA has issued the guidance Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products . Published in 12 Dec
Sharan Murugan
Dec 13, 20254 min read
USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...
Sharan Murugan
Jul 22, 20242 min read