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Part 1: India Works on Guidelines for Biological Products


India entered the biosimilar market early and has nearly 100 approved biosimilars, but experts say its regulatory system is not considered world-class, which may hinder international marketing of these products.

Although India’s domestic biosimilar market is on the rise, international business may be impeded by a loose regulatory structure that makes other nations wary of the quality of the country biosimilars, according to biopharmaceutical and legal experts.

Currently, there are 98 approved biosimilars in India, with at least 50 on the market, the most of any country in the world. For comparison, the United States has 26 approved biosimilars and the European Union had 61, according to a survey by the World Health Organization (WHO).

For this 2-part article, The Center for Biosimilars® examines India’s efforts to tighten its regulations governing biosimilar development, some of the lingering downsides of this regulatory structure, and the challenges facing Indian biopharmaceutical companies that are looking to compete in global markets.

In an interview with The Center for Biosimilars®, Sarfaraz Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the College of Pharmacy at the University of Illinois at Chicago, said that very few Indian biopharmaceutical companies have been able to penetrate the US and European markets because many of India’s regulations are looser than those drafted by the FDA, European Medicines Agency, and WHO.

The country developed its first biosimilar in 2000, well ahead of Europe, which approved its first biosimilar in 2006. The regulations stem from biosimilar guidelines originally drafted in 2012 by 2 Indian governmental agencies, the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT), meant to address and improve the development and approval process for biosimilars. The guidance was most recently revised in 2016.

However, there are some conflicting opinions on whether or not the guidance and its revisions have made a difference in ensuring that biosimilars perform as well as their originator products.

Benefits of CDSCO and DBT Guidelines

The CDSCO and DBT guidelines have enabled manufacturers to bypass phase 3 clinical trials in circumstances where sufficient pharmacodynamic (PD) and pharmacokinetic (PK) data are available, opening the door for faster product approvals. The requirements for safety and efficacy trials can also be waived for such products if PD and PK data are available.

“Just having a system in place that defines what tests will be needed is a very critically important distinction,” said Imron T. Aly, a patent attorney with Schiff Hardin LLP who regularly handles legal affairs for Indian biopharmaceutical companies, in an interview with The Center for Biosimilars®. He said the guidelines have relieved manufacturers of having to conduct redundant studies, which makes bringing a product to market more achievable.

Prior to the revisions, a reference product had to be approved and marketed in India if a manufacturer wanted to base its biosimilar on that particular product. The changes allow Indian companies to develop biosimilars based on reference products approved in the European Union, Japan, United States, Canada, and Switzerland.

Additionally, CDSCO and DBT included a requirement for phase 4 postmarketing trials, which must include at least 200 study participants and be conducted within 2 years of market approval.

In part 2 of this article, The Center for Biosimilars® examines downsides of the CDSCO and DBT guidelines, along with challenges Indian companies face when bringing their biosimilars to the international market.


Meher BR, Balan S, Mohanty RR, Jena M, Das S. Biosimilars in India; current status and future perspectives. J Plarm Bioallied Sci. 2020;11(1):12-15. doi:10.4103/jpbs.JPBS_167_18

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