Data Requirements for Biosimilars Published 2018-05-22 Download video MP4 360p Download video MP4 720p Recommendations 04:20 The Biosimilar Development Process 04:12 The Basics of Biosimilars 04:20 The Concept of Interchangeability 03:33 Biosimilars: Manufacturing and Inherent Variation 03:12 Biosimilars: Critical Quality Attributes 02:47 Biosimilars: Approval Process 02:05 What Are Biomarkers And Why Are They Important? 10:29 Idea to IDE: A Medical Device in the Making 02:02 5 Things You Need to Know About the Drug Approval Process 03:07 The Promise of Biosimilars 05:33 Biomarker Terminology: Speaking the Same Language 03:00 Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI) 16:18 How is My Medical Device Classified? 01:36 Interchangeable Biosimilars 01:58 FDA Review and Approval Process for Biosimilar Medications 42:43 Regulatory Highlights for Biosimilars and Interchangeables (9of15) REdI – May 29-30, 2019 30:40 MEDIA CALL: FDA’s Final Rule on Laboratory Developed Tests – 04/29/2024 50:52 Navigating FDA's Drug Information Resources 04:16 Total Product Lifecycle Advisory Program (TAP) Engagement with Device Developers 2:51:28 Increasing the Efficiency of Biosimilar Development Programs (Day 2) Similar videos 14:19 Regulatory Pathway for Biosimilars 01:45 What is a Biosimilar? - Video Explainer 01:44 Fast Facts About the Regulatory Approval Pathway for Biosimilars – Amgen Science 13:22 Freyr Regulatory Radio: Season 4 | E 3 - CMC Requirements for Biologics/Biosimilars 08:20 Pharmacovigilance Requirements for Biosimilar Products 19:39 02 THE US BIOSIMILARS REGULATORY PATHWAY 01:10 Biosimilars: Clinical data 02:03 Biosimilars Interchangeability 00:43 Fast Facts about Biosimilars - Amgen Science 04:36 The Extrapolation of Biosimilar Indications: Understand the Practical Implications 47:11 Biosimilar and India Regulations 13:14 (Review) Review of Biosimilar More results