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**Introduction**

Biologic therapies have revolutionized the treatment of various chronic diseases, offering new hope for patients with conditions such as cancer, autoimmune disorders, and inflammatory diseases. However, the high cost of biologic drugs has limited their accessibility to many patients, creating a need for more affordable alternatives. Biosimilars, which are highly similar versions of approved biologic drugs, have emerged as a promising solution to this issue. The development of biosimilars offers the potential to increase access to life-saving treatments while reducing healthcare costs. This thesis aims to explore the development of biosimilars for biologic therapies, focusing on the challenges, opportunities, and implications of this emerging field.

**Table of Contents**

**Chapter 1: Introduction**
1.1 Introduction
1.2 Background of study
1.3 Problem Statement
1.4 Objective of study
1.5 Limitation of study
1.6 Scope of study
1.7 Significance of study
1.8 Structure of the Thesis
1.9 Definition of Terms

**Chapter 2: Literature Review**
2.1 Overview of biologic therapies
2.2 Introduction to biosimilars
2.3 Regulatory landscape for biosimilars
2.4 Challenges in developing biosimilars
2.5 Clinical considerations for biosimilars
2.6 Economic implications of biosimilars
2.7 Market dynamics of biosimilars
2.8 Case studies of successful biosimilar development
2.9 Patient and physician perspectives on biosimilars
2.10 Future directions in biosimilar research

**Chapter 3: Research Methodology**
3.1 Research design
3.2 Data collection methods
3.3 Sample selection
3.4 Data analysis techniques
3.5 Ethical considerations
3.6 Pilot testing
3.7 Limitations of the study
3.8 Strengths of the study

**Chapter 4: Discussion of Findings**
4.1 Overview of research findings
4.2 Comparison of biosimilars and reference biologics
4.3 Implications for clinical practice
4.4 Health policy considerations
4.5 Market access challenges
4.6 Future research directions
4.7 Recommendations for stakeholders
4.8 Conclusion

**Chapter 5: Conclusion and Summary**
5.1 Summary of key findings
5.2 Contributions to the field
5.3 Implications for practice
5.4 Limitations of the study
5.5 Recommendations for future research
5.6 Conclusion

This thesis will provide a comprehensive overview of the development of biosimilars for biologic therapies, addressing key issues such as regulatory pathways, clinical considerations, market dynamics, and patient perspectives. By examining the challenges and opportunities in this rapidly evolving field, this study aims to inform policymakers, healthcare providers, and patients about the potential of biosimilars to improve access to essential treatments.

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