| Description |
1 online resource (436 pages) |
| Contents |
Cover; Half Title; Title Page; Copyright Page; Dedication; Table of Contents; About the author; Other selected books by the author; Bibliography; 1. The motivation; 2. The vocabulary; 3. About first biosimilar originators; 4. Purple book; 5. Biosimilar markets; 5.1 Biosimilars misconceptions; 6. About this book; Bibliography; Disclaimer; Chapter 1: Understanding proteins; 1.1 Background; 1.1.1 Developing biosimilars; 1.2 Protein structure; 1.2.1 Building elements; 1.2.2 Translation; 1.2.3 Peptide bond; 1.3 Motifs and domains; 1.4 Association and aggregation; 1.5 Posttranslational modification |
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1.5.1 Glycosylation1.6 Protein expression variability; Bibliography; Chapter 2: The biosimilar landscape; 2.1 Background; 2.2 The rise of biosimilars; 2.2.1 Legislative history; 2.2.2 Regulatory guidance; 2.2.3 The 351(k) Route; 2.2.3.1 What interchangeable or interchangeability means; 2.2.3.2 The totality-of-the-evidence approach; 2.2.4 The FDA stance; 2.2.5 351(k) Terminology; 2.2.5.1 Innovator versus originator; 2.2.5.2 Authorized versus licensed; 2.2.5.3 Medicines versus drugs; 2.2.5.4 Similarity versus comparability; 2.2.5.5 Effectiveness versus efficacy |
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2.2.5.6 One-size-fits-all versus case-by-case2.2.5.7 Totality of the evidence; 2.2.5.8 No clinically meaningful difference; 2.2.5.9 Fingerprint-like similarity; 2.2.5.10 Extrapolation; 2.2.5.11 Label copy; 2.2.5.12 Interchangeable biosimilars; 2.2.5.13 Pediatric waiver; 2.3.2.14 Impurity versus attributes; 2.3 Biosimilars in use; 2.3.1 FDA-Approved biosimilar products; 2.3.2 Future of biosimilars; 2.3.2.1 Global mind-set; 2.3.2.2 Immediate needs; Bibliography; Chapter 3: The FDA regulatory guidance; 3.1 Background; 3.2 Overview of the FDA guidance; 3.3 Formal meetings |
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3.3.1 Biosimilar initial advisory meeting3.3.2 Biosimilar biological product development (BPD) Type 1 meeting; 3.3.3 BPD Type 2 meeting; 3.3.4 BPD Type 3 meeting; 3.3.5 BPD Type 4 meeting; 3.4 Scientific considerations; 3.4.1 Background; 3.4.2 Complexities of protein products; 3.4.2.1 Nature of protein products and related scientific considerations Unlike small-molecule drugs, whose structure can usually be completely defined and entirely reproduced, proteins are typically more complex and are unlikely to be shown to be structu |
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3.4.2.2 Manufacturing process considerations Different manufacturing processes may alter a protein product in a way that could affect the safety or the effectiveness of the product. For example, differences in biological systems used to manufacture a prot3.4.3 U.S.-licensed reference product and other comparators; 3.4.4 Approaches to developing and assessing evidence to demonstrate biosimilarity |
| Summary |
The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy |
| Notes |
3.4.4.1 Using a stepwise approach to demonstrate biosimilarity The purpose of a biosimilar development program is to support a demonstration of biosimilarity between a proposed product and a reference product, including an assessment of the effects of any |
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Print version record |
| Subject |
Drugs -- Generic substitution.
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Pharmaceutical biotechnology -- United States
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Pharmaceutical biotechnology.
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Biosimilar Pharmaceuticals
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Drug approval.
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Government Regulation
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United States Government Agencies
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MEDICAL -- Pharmacology.
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Drug approval
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Drugs -- Generic substitution
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Pharmaceutical biotechnology
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United States
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| Form |
Electronic book
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| ISBN |
9781498750400 |
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1498750400 |
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