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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Export pattern of Indian biosimilar pharmaceutical products: A Study of select Indian pharmaceutical companies

Author: GYAN UJALAYAN, SHIBU JOHN, PRERNA SINGH
Abstract: The fundamental principle for the development of biosimilars involves the selection of an adequate reference product, development of an effective manufacturing process, achieving the standards of quality control, con-ducting both preclinical and clinical studies. India's initial guidelines were brought into effect in 2012 and were further revised in 2016. Biosimilar drugs have the potential to cause higher progression and rapid develop-ment in the manufacturing industry in the near future. The Indian market is already enjoying a significant in-crease in the biosimilar manufacturing sector. Out of the USD 32 billion Indian pharmaceutical market, biosim-ilar products occupy a share of 2 billion dollars. It has been projected to grow annually at a rate of around 30%, reaching around 40 billion dollars by 2030. This growth will be propelled further due to an increasing number of biologic patents expiring in the next few years. In India, biosimilar development cost falls around 10-20 million USD due to the extensive regulatory procedures. Biosimilar makers face unusual problems in the development process, clinical improvement, manufacturing, registration, product marketing, and ongoing com-petition which reduces the entry of new players and restrains the market growth. The regulatory environment of the global pharmaceutical market is becoming more stringent and impacting exports. Several other factors, such as inequalities in the stringency of regulations, the flow of investment funds and unclear market maturity trends have served as deterrents in the active pursual of the global markets by Indian players. In order to make the Indian Pharmaceutical industry globally competitive, an active and smooth regulatory set-up is integral. This article implies that nurturing the flourishing industry landscape is critical. The players in the industry must be provided with adequate resources to take on commercial challenges faced during market entry, mak-ing both domestic and international markets more accessible to aid the multiplication of export opportunities and fully harness the existing ones.
Keyword: Biosimilars; Regulations; Efficacy; Guidelines; Exports
DOI: https://doi.org/10.31838/ijpr/2020.12.03.019
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