Therapeutic equivalence of biogenerics: regulatory and development issues (Part-II)
Date
2008
Authors
Reddy, S.E.
Manasi, M.
Narasu, L.
Lalla, J.K.
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Advisors
Journal Title
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Volume Title
Type:
Journal article
Citation
The Pharma Review, 2008; April/May:61-67
Statement of Responsibility
Conference Name
Abstract
Part-I of this article entitled ‘Research, Product Development And Production of Biotech Derived Pharmaceuticals’ has been published in October 2007 issue of this journal. The present article covers therapeutic equivalence of biotechnology derived pharmaceuticals. The objective of writing this article is to assist the Pharma and biotech industry in guiding for establishing therapeutic equivalence of Biotech-Derived Pharmaceuticals which need to be produced in India and exported globally. The honorable finance minister Shri P Chidambaram has given incentives in the current budget for the Research areas, 'Biotech-Derived Pharmaceuticals' being the grey area can benefit from this announcement.This article covers “Regulatory Filing strategies” for biogenerics which may help Indian industry in deciding to invest in biotech industry. The article also emphasizes on Quality aspects of biotech derived Pharmaceuticals which is essential for export promotion.