Biosimilars in India; current status and future perspectives

• Published in: Journal of pharmacy & bioallied science Vol. 11; no. 1; pp. 12 - 15
• Main Authors: Meher, Bikash, Balan, Sakthi, Mohanty, Rashmi, Jena, Monalisa, Das, Smita
• Format: Journal Article
• Language: English
• Published: India Wolters Kluwer India Pvt. Ltd 01.01.2019; Medknow Publications and Media Pvt. Ltd; Medknow Publications & Media Pvt. Ltd; Medknow Publications & Media Pvt Ltd; Wolters Kluwer Medknow Publications
• Subjects: Analysis; Biological products; Biopharmaceuticals; Biosimilar pharmaceuticals; Biosimilars; Cancer therapies; Deoxyribonucleic acid; DNA; Drugs; European Medicines Agency; FDA approval; Food and Drug Administration; Gene expression; Genetic engineering; Manufacturing; Marketing; Medical care, Cost of; Pharmaceutical industry; Regulatory agencies; Review; similar biologics; United States; India; United States > US; Europe; Biosimilars; similar biologics; European Medicines Agency; Food and Drug Administration
• ISSN: 0975-7406; 0976-4879; 0975-7406
• DOI: 10.4103/jpbs.JPBS_167_18

Many key biologics are scheduled to lose their patent by the year 2020, which will provide the opportunity to other biopharmaceutical companies to develop the similar biologics. Biosimilar or similar biologic used has increased in the recent year following the approval of the first biosimilar in early 2000. India is one of the leading manufacturers of similar biologics. India has developed a new guideline in 2012 for the pre- and post-marketing approval of similar biologics.