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Introduction:

The development of biosimilars has emerged as a promising area within the pharmaceutical industry, offering the potential to provide more affordable alternatives to biologic drugs. Biosimilars are highly similar versions of approved biologic drugs, manufactured by different companies after the original drug’s patent expires. However, the regulatory approval process for biosimilars presents several challenges compared to small-molecule generic drugs. This thesis aims to explore the development of biosimilars and address the regulatory challenges they face.

Chapter One: 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 Two: Literature Review
2.1 Overview of biosimilars
2.2 Regulatory framework for biosimilars
2.3 Clinical trials for biosimilars
2.4 Market dynamics of biosimilars
2.5 Pricing and reimbursement considerations
2.6 Safety and efficacy of biosimilars
2.7 Challenges in manufacturing biosimilars
2.8 Pharmacovigilance considerations
2.9 Physician and patient acceptance
2.10 Global perspectives on biosimilars

Chapter Three: Research Methodology
3.1 Research design
3.2 Data collection methods
3.3 Sampling techniques
3.4 Data analysis procedures
3.5 Research limitations
3.6 Ethical considerations
3.7 Validity and reliability of data
3.8 Research implications

Chapter Four: Discussion of Findings
4.1 Overview of research findings
4.2 Comparison of biosimilars and reference biologics
4.3 Regulatory challenges in biosimilar development
4.4 Market access challenges
4.5 Physician and patient perspectives
4.6 Recommendations for improving biosimilar adoption
4.7 Impact of biosimilars on healthcare systems
4.8 Future outlook for biosimilars
4.9 Collaboration opportunities in biosimilar development
4.10 Policy implications for biosimilar regulation

Chapter Five: Conclusion and Summary
5.1 Summary of key findings
5.2 Contributions to the field
5.3 Implications for future research
5.4 Conclusion
5.5 Recommendations for policymakers and stakeholders

Thesis Overview:

The development of biosimilars has gained momentum in recent years as a means of providing cost-effective alternatives to biologic drugs. However, the regulatory challenges facing biosimilar manufacturers have been a significant barrier to their widespread adoption. This thesis aims to provide a comprehensive analysis of the development of biosimilars and the regulatory challenges they face. The literature review will examine the current landscape of biosimilars, including regulatory frameworks, clinical trials, market dynamics, pricing considerations, safety, and efficacy issues, manufacturing challenges, and pharmacovigilance considerations. The research methodology will outline the approach taken to investigate biosimilars’ development and regulation, including data collection methods, analysis procedures, and ethical considerations. The discussion of findings will present an in-depth analysis of the key challenges facing biosimilar development, including regulatory hurdles, market access issues, and physician and patient perspectives. The conclusion will summarize the key findings, highlight the contributions to the field, and provide recommendations for policymakers and stakeholders. Overall, this thesis aims to shed light on the development of biosimilars and offer insights into how regulatory challenges can be addressed to promote their successful adoption in healthcare systems worldwide.

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