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Table of Contents:

Chapter 1: Introduction
1.1 Background of the Study
1.2 Rationale for the Study
1.3 Objectives of the Study
1.4 Research Questions
1.5 Scope of the Study
1.6 Limitations of the Study

Chapter 2: Literature Review
2.1 Introduction to Biosimilar Drugs
2.2 Development of Biosimilar Drugs
2.3 Regulation of Biosimilar Drugs
2.4 Challenges in Developing and Regulating Biosimilar Drugs
2.5 Current Trends in Biosimilar Drug Development and Regulation

Chapter 3: Research Methodology
3.1 Research Design
3.2 Data Collection Methods
3.3 Data Analysis Techniques
3.4 Sampling Techniques
3.5 Ethical Considerations

Chapter 4: Discussion of Findings
4.1 Overview of Biosimilar Drug Development
4.2 Regulatory Framework for Biosimilar Drugs
4.3 Challenges Faced in Developing and Regulating Biosimilar Drugs
4.4 Comparative Analysis of Biosimilar Drugs
4.5 Recommendations for Improving Biosimilar Drug Development and Regulation

Chapter 5: Conclusion and Summary
5.1 Summary of Findings
5.2 Conclusion
5.3 Implications for Practice
5.4 Recommendations for Future Research
5.5 Final Remarks

Brief Overview on Thesis “Biosimilar Drugs: Development and Regulation”:

Biosimilar drugs have gained significant attention in the pharmaceutical industry as cost-effective alternatives to expensive biologic drugs. However, the development and regulation of biosimilar drugs present unique challenges that require careful consideration. This thesis aims to explore the development and regulation of biosimilar drugs, with a focus on the current trends, challenges, and regulatory frameworks in place.

The literature review will provide an overview of biosimilar drugs, their development process, and the regulations governing their approval and market access. The research methodology will outline the research design, data collection methods, and analysis techniques used to examine the topic.

The discussion of findings will delve into the key issues surrounding biosimilar drug development and regulation, including challenges faced by manufacturers and regulators, as well as recommendations for improving the development and regulation process. The conclusion and summary will recap the main findings of the study and provide implications for practice and recommendations for future research in the field of biosimilar drug development and regulation.

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