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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
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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Similar Biologics: Current Summary and Future Outlook

Author: ABHISHEK KERALLI, R SURESHKUMAR
Abstract: Standpoint most biologics around the globe are planned to lose their entitlement to copyrights by upcoming years. When the pioneer loses their patent, which gives other biologic or biosimilar producers opportunities to extend the follow-on biologics. In recent years, the use of similar biotherapeutic products has risen, going to back the approval of the first similar biotherapeutic product in early 2000. India is one of the major producers of similar biologics. In 2016, CDSCO portrayed new standards for the pre- and post-marketing approval of similar biologics or subsequent entry biologics.
Keyword: Biologics, Biosimilar, CDSCO, EMA, FDA, r-DNA technology.
DOI: https://doi.org/10.31838/ijpr/2020.12.04.040
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