Volume : VII, Issue : VI, June - 2017

Tapping the Regulatory Hurdles of Biosimilars: Marketing Authorization across European Union

Varun Reddy Thummala, Jayapal Reddy A. V, Dr. Praveen Shetty, Krishna Kishore A

Abstract :

 Background: The European Medicines Agency (EMA) has led the way in the development of regulatory guidelines for the development and assessment of biosimilars by providing an overarching regulatory approval framework for biosimilars and subsequently approving its first biosimilar the following year in 2006. The complexity of establishing bio–similarity with reference biological product lies in the way of developing biosimilars in compliance with regulatory path. Objective: The objective of the study is to assess the Regulatory aspects of Biosimilars in the European Union. Methods: Researcher has adopted an exploratory design with the Dual approach system to establish the objectivity of the research study. Findings: Through the totality of evidence approach in alignment with the ABCE of biosimilars and ascertaining the evidence data points in the registration dossier for marketing authorization, streamlines the regulatory challenges buckled for the marketing approval of biosimilars in the European Union. Conclusion: Tapping the regulatory hurdles relies on the deployment of totality–of–evidence approach to establish biosimilarity in line with reference biologic.

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Article: Download PDF   DOI : 10.36106/ijar  

Cite This Article:

Varun Reddy Thummala, Jayapal Reddy A.V, Dr. Praveen Shetty, Krishna Kishore A, Tapping the Regulatory Hurdles of Biosimilars: Marketing Authorization across European Union, INDIAN JOURNAL OF APPLIED RESEARCH : Volume‾7 | Issue‾6 | June‾2017

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