Geeta Aggarwal, Manju Nagpal*, Ameya Sharma, Vivek Puri and Gitika Arora Dhingra Pages 1-13 (13)
Methods: Appraisal of published articles from peer reviewed journals, PubMed literature, latest news and guidelines from European Medicine Agency, US Food Drug Administration (FDA) and India are used to identify data for review.
Results: Main insight into the quality requirements concerning biologics, current status of regulation of biosimilars and upcoming challenges lying ahead for the upgrading of marketing authorization of bio-similars has been incorporated. Compiled literature on therapeutic status, regulatory guidelines and the emerging trends and opportunities of biosimilars has been thoroughly stated.
Conclusion: Updates on biosimilars will support to investigate the possible impact of bio-similars on healthcare market.
Biologics, bio-similars, regulatory, EMA, FDA, global market
Delhi Pharmaceutical Sciences and Research University, New Delhi-110017, Chitkara College of Pharmacy, Chitkara University, Punjab, Chitkara College of Pharmacy, Chitkara University, Punjab, Chitkara College of Pharmacy, Chitkara University, Punjab, NCRD’S Sterling Institute of Pharmacy Navi Mumbai