Abstract

The Recent Trend in Bio-Similar Drugs Development

Highlights

  • Bio-Similar is the fastest growing field of pharmaceutical industries

  • The Pharmacovigilance is an important soul for the extra knowledge and for the safety data for the Bio-Similar due to the

  • Traceability and proactive risk management is very important for the knowledge about the safety of the Bio-Similar and the immunogenicity is important

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Summary

Introduction

Bio-Similar is the fastest growing field of pharmaceutical industries They were produced mainly by (Recombinant DNA technology-antibody/monoclonal body’s technologies). This has provided many cures and prevention to some life Dangerous illness such as Diabetes, rheumatoid arthritis, cancer, inflammatory etc. This has produced a wide range of product like growth hormone, insulin, recombinant vaccines and gene cloning product. Bio-Similars are approved based on part on the studies done with the reference product. It is possible to produce a specific mAb to almost any extracellular/cell surface target, indicated by the ubiquitous amount of research and development currently being conducted to generate monoclonal antibodies against numerous diseases that are difficult to treat by drug therapy or surgery.

Indication
Secondary endpoint
Review Committee on genetic manipulation
Conclusion
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