Biosimilars Development Strategies

Preface

Chapter 1 All About Biosimilars

1. Introduction

2. Approvals

3. Future Candidates

4. Approval Guidelines

5. Waivers

6. Appendix: Terminology

7. Appendix 2: Therapeutic Proteins approved by the FDA: potential biosimilar candidates.

8. Bibliography

Chapter 2 Product Type and Selection Strategies

1. Background

2. Exclusivity

3. Formulation

4. Route of Administration

5. Reference Product

Chapter 3 Development Master Plan

1. Introduction

2. Creating a Plan

3. Intellectual Property

4. Expression System

5. Release Specification

6. Nonclinical Testing

7. Clinical Pharmacology Assessment

8. Clinical Immunogenicity Assessment

9. Clinical Efficacy Assessment

10. Extrapolation of Clinical Data Across Indications

11. Interchangeability and Substitution

Chapter 4 Optimization of Cost of Goods

1. Background

2. Creation of Cell Lines

3. Media

4. Containers and Mixing Systems

5. Working downstream

6. Regulatory

7. Ongoing Production

8. Continuous Manufacturing

Chapter 5 Strategic Understanding for Biosimilars Future

1. Introduction

2. The Role of the US Congress

3. The Role of the FDA

4. The Role of Developers

5. The Role of the Associations

6. Conclusions

Chapter 6 Repurposing Biosimilars

1. Introduction

2. Understanding Therapeutic Proteins

3. Reinvention Scope

4. Intellectual Property

5. Artificial Intelligence (AI) and Machine Learning (ML)

6. Structure Prediction

7. Target identification

8. Molecular Docking

9. Drug Conjugates

10. Regulatory Perspective

11. Conclusions

12. References