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Upcoming Drifts in Bio-similars

[ Vol. 15 , Issue. ]


Geeta Aggarwal, Manju Nagpal*, Ameya Sharma, Vivek Puri and Gitika Arora Dhingra Pages 1-13 (13)


Background: Biopharmaceuticals such as Biologic medicinal products have been in clinical use over the past three decades and have benefited towards the therapy of degenerative and critical metabolic diseases. It is forecasted that market of biologics will be going to increase at a rate of 20% per year, and by 2025, more than ˃ 50% of new drug approvals may be biological products. The increasing utilization of the biologics necessitates for cost control, especially for innovators products that have enjoyed a lengthy period of exclusive use. As the first wave of biopharmaceuticals is expired or set to expire, it has led to various opportunities for the expansion of bio-similars i.e. copied versions of original biologics with same biologic activity. Development of biosimilars is expected to promote market competition, meet worldwide demand, sustain the healthcare systems and maintain the incentives for innovation.

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

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