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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2013)

Regulatory and Pharmacovigilance Aspects of Biosimilars Medicinal Products

Dr. Gaurav Pathak1 & Dr. Rachana2

Introduction: The regulatory burden of biosimilar approvals is substantial, both logistically and economically, but the reward is a portion of more than $100 billion (US) in sales, more than $25 billion each in oncology or immunology or inflammation, and more than $15 billion in diabetes. Biosimilars are, of course, a new paradigm in drug development, and are currently in a position of acceptance similar to that of generic medicines in the 1980s. Stakeholders in biosimilars are not only patients but also the pharmaceutical industry, regulators and physicians. Besides the heavy regulatory burden, peer acceptance by key medical opinion leaders is an issue that continues to be discussed in individual cases. This resistance to accept biosimilars is made evident by slow penetration of EU national markets, unfavorable survey results in the EU and US, critical articles and lectures by opinion leaders and a lack of interest in a deeper understanding of biosimilars by some medical journals and associations. 

 

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