Part 2: Panelists Advise Patterning Guidelines on International Standards

In part 2 of this panel discussion with The Center for Biosimilars®, 3 experts explore strategies that India could take to improve the perception of its biologics and biosimilars.

Affordable Production and Perception Issues

Anurag Rathore, PhD, a professor in the Department of Chemical Engineering at the Indian Institute of Technology in Delhi, India, suggests several ways that India could reduce prices of biologics, including using multiple manufacturers. Additionally, Rathore says that switching from batch production to continuous processing could reduce manufacturing costs by 70% to 80%.

Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar, suggests that streamlining clinical trial requirements could help with affordability. He also states that he would like to see more transparency from India regarding cost and quality of biologics, such as a ranking system.

Sarfaraz K. Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois, Chicago, and an entrepreneur, said that because regulatory agencies are in a learning phase, the biosimilars produced may not measure up to global quality standards.

Potential Solutions

Rathore comments on the length of time it’s taken for regulators in Asia to agree on bioequivalence standards for generic drugs and how that also applies to the biologics industry. He expresses concern that regulators could repeat past mistakes of taking too long to agree, which could lead to physicians being more hesitant to use biosimilars.

He suggests that India could adopt guidelines from the World Health Organization, the European Union, China, Japan, or the United States to develop their products and develop its own internal regulations over time.

Niazi remarks that Indian companies are developing too many biologics with different manufacturing techniques, which affects quality and consistency, but he believes that with motivation, these producers will eventually have an opportunity to participate in the broader market for biologics.

Rathore explains the difference between manufacturers that target global markets, who have a larger responsibility to follow international guidelines, and ones that target Indian or low- and middle-income markets.

He says that regulators need to get to a point where the size of the manufacturer doesn’t matter. He added that the evaluation process needs to be robust enough so that all products that receive approval are ones that should be allowed on the market and that there should be no room for error.

Cornes discusses biologics prequalification designations, which are general statements of support of a drug from the World Health Organization. These, he says, are a great idea to help lessen the workload for small- and middle-income countries when developing medications. However, he worries that the World Health Organization is mostly focused on essential medicines, meaning that prequalification determinations for other drugs could take a much longer time.

He suggests that shared common technical dossiers could be used as another standard and that he would feel comfortable with that. He says that if India could make policies like this happen, itwould be a very positive change.