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Part 2: Modifications Could Help India's Biosimilars Powerhouse


Although India is far ahead of other countries in terms of biosimilar approvals, its regulatory structure may hinder efforts for international sales.

See part 1 of this article here.

With a thriving domestic market for biosimilars, India ranks first in the world for the number of approvals (98), but the country’s guidelines for biologics development are not considered to be as demanding as those of the United States, the European market, or the World Health Organization (WHO).

It’s for this reason that India is thought to be challenged in its ability to launch biosimilar products on the world stage. Part 1 of this article looked at regulatory changes in the country. In part 2, we look at perceived weaknesses in regulatory guidance for Indian biologics and compare the pros and cons of the American and Indian systems for biosimilar approval.

Although the guidelines in India have been revised, they still fall short on animal testing, said Sarfaraz Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the College of Pharmacy at the University of Illinois at Chicago, in an interview with The Center for Biosimilars®. The guidelines instead suggest that monoclonal antibodies be tested on rats, which provide limited valuable data on the potential effects of the drugs in humans, he said.

“Monoclonal antibodies have no toxicity in rodent species because those rodents don't have receptors. You can literally pump a pound of this antibody in a rat and nothing will happen. So, all the studies are totally useless,” Niazi said.

Also, he added, immunogenicity tests used to measure the power of agents to stimulate an immune system response are conducted solely in animals, which fails to provide a full picture of how biosimilars will affect humans, owing to dissimilarities in the way animals and humans react.

Biosimilars must be similar to reference products in terms of safety and efficacy, so how these tests are done and their results are very important, Niazi said. For example, drugs should not significantly exceed the efficacy of the reference products they are intended to imitate, because a biosimilar with greater potency than its reference product may lead to more serious adverse events.

Improper standards may mean some products don’t truly qualify as biosimilars, Niazi said. “I'm not saying the Indian products are not safe or effective. My point is that your product may be effective, but it is not a biosimilar. And I think that difference has not gone through the minds of those who are sitting in the [Central Drugs Standard Control Organization].”

Niazi noted that the statistical validity of some trials is also questionable, because many trials in India recruit only 100 or so participants.

India Needs World-Class Standards

Niazi specified that one of the biggest issues for India’s goals for international biosimilar trade is that testing requirements do not equal the FDA, European Medicines Agency, and WHO regulations that many countries with biosimilar markets either use or emulate in their own national guidance.

“Nobody will take these products seriously until they start complying with what is considered to be scientifically sound guidance for development,” said Niazi. “What they're finding out is that they literally have to go back to square one [in product development] for them to have any chance of coming into the US market.”

Imron Aly, a patent attorney with Schiff Hardin LLP, who regularly handles legal affairs for Indian biopharmaceutical companies, said in an interview with The Center for Biosimilars® that he believes India’s technical expertise, vast experience with generics development, and huge density of scientists will help them overcome international challenges.

The Indian biosimilar market remains robust, as evidenced by the large number of biosimilar products, and there have been international successes. Aly said Biocon, based in Bangalore, is a good example of an Indian biopharmaceutical company that has successfully entered the US market. In partnership with the Canonsburg, Pennsylvania-based company Mylan, Biocon has launched 2 biosimilars on the US market: a pegfilgrastim and a trastuzumab. The company was able to achieve that via its Mylan partnership.

Most Indian companies that are engaged in biosimilar manufacturing do not attempt to break into the US market, Aly said. “There seems to be eagerness from Europe and South America to develop and expand biosimilars in the United States. The litigation cost is just a high burden that [Indian companies] are shying away from for the time being.”

Biocon has been willing to do battle with patent holders in court. In March 2020, the company won a court ruling that invalidated a Sanofi patent that blocked Biocon and Mylan from commercializing an insulin glargine product in the United States.

Differences Between the United States and India

Unlike the United States, India does not require biosimilars to pass an “interchangeability” test to allow pharmacists to switch patients from reference products without physician permission. This is a good thing, Niazi and Aly agreed. The United States is the only nation that requires a biosimilar interchangeability designation for this purpose, they said. This designation limits patient access to these cheaper biologics. In India, biosimilars can be substituted at the pharmacy level without a physician’s approval.

Another big difference is the perception of biosimilars. Whereas US physicians and patients may be uninformed or misinformed about the safety and efficacy of biosimilars, in India, the government and society encourage people to search for cheaper alternatives, Aly said.

Additionally, statistics suggest that when it comes to health care, the Indian population is more price sensitive. Many households do not have health coverage, and it is estimated that 82% of health care costs in India are paid out of pocket. “If there is a cheaper alternative [for a prescription], it will naturally go out in the private market,” said Aly.

Another difference between India and the United States is the rate of uptake of biosimilars. India approved its first biosimilar in early 2000, long before the European Union (2006) and the United States (2015).

“It's very rapid growth, and a large part of that is because [private] investment in pharmaceuticals research and development in India is very high,” said Aly.


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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