REGULATORY REQUIREMENTS OF ‘SIMILAR BIOLOGICS’ FOR MARKETING AUTHORIZATION IN INDIA
Present article signifies the exigency for regulation and regulatory bodies involved in development of biosimilars. The principle for development of biosimilars included opting adequate reference product, manufacturing process optimization, quality control procedure, preclinical and clinical studies. India’s first guidelines were enforced in 2012, with amendments in 2016. Thus, we elaborated the amended guidelines for development of biosimilars.
2. EMA Guideline on Similar Biological medicinal products containing biotechnology‐derived proteins as active substance: non‐clinical and clinical issues, London: (EMEA/CHMP/BMWP/42832/ 2005 Rev1); 2014.
3. Guideline for Safety Study of Biological Products (KFDA); 2010.
4. World Health Organization (WHO) Guidelines on Evaluation of Similar Bio therapeutic Products (SBP); 2009.
5. GaBI Online. ‘Similar biologics’ approved and marketed in India-Generics and Biosimilars Initiative [Internet]. Generics and Biosimilars Initiative; 2017 [Cited 2016 Feb 3]. Available from:
6. EMA guideline on Similar Biological medicinal products containing biotechnology derived proteins as active substance: non‐clinical and clinical issues. London: (CHMP/BMWP/42832); 2006.
7. EMA guideline on immunogenicity assessment of biotechnology‐derived therapeutic proteins London: (CHMP/ BMWP/14327); 2007.
8. ICH guideline on preclinical safety evaluation of biotechnology‐derived pharmaceuticals (S6), 1997 and addendum, 2011.
9. RAPS. Biosimilar Medicinal Products: Innovation in Regulatory Review and Approval. [Internet]. RAPS; 2012, Jun [Cited 2016 Feb 3]. Available from:
http://www.raps.org/focus-online/ features/ features-article-view/article/1838/biosimilar-medicinal-products-innovation-in-regulatory-review-and-approval.aspx
10. EMA‐ DNA and Host cell protein impurities routine testing versus validation studies, 1997 X. ICH Q1 A(R2)‐ Stability Testing of New Drug Substances and Products; 2003.
11. World Health Organization (WHO), Guidelines on the quality, safety and efficacy of bio‐therapeutic protein products prepared by recombinant DNA technology; 2013.
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