The FDA recently released a comprehensive guide – “9 Things to Know About Biosimilars and Interchangeable Biosimilars” on biosimilars and interchangeable biosimilars, emphasizing their safety, effectiveness, and potential to increase patient access to biologic medications.
These highly similar versions of FDA-approved reference products promise no clinically meaningful differences in safety, purity, or potency, potentially offering significant cost savings. The guiding article highlighted the positive impact of biosimilars on public health in the U.S., noting substantial patient treatment days and improved health equity. However, the regulatory landscape and adoption practices differ globally. To contextualize these findings for the Indian market, we spoke with Dr.Shubhadeep Debabrata Sinha, a leading expert in the field, to explore the relevance, challenges, and potential benefits of biosimilars in India.
Dr. Sinha is a distinguished leader in pharmaceutical and healthcare innovation, with over 24 years of experience. As Senior Vice President of Development at Hetero, he has significantly advanced drug discovery, clinical research, and medical development. Dr. Sinha holds an M.B.B.S., M.D., and numerous specialized diplomas, including from IIM Calcutta and the University of Hyderabad. He has led numerous clinical trials, particularly in biosimilars, HIV, oncology, and gastroenterology. With approximately 40 peer-reviewed publications, Dr. Sinha is a respected mentor and educator, dedicated to nurturing future healthcare leaders and advancing global health.
In this exclusive interview with Neo Science Hub, Dr. Sinha provides valuable insights into regulatory frameworks, prescriber acceptance, and the economic implications of wider biosimilar adoption in India.
The article by the US Food & Drug Administration (FDA) on biosimilars and interchangeable biosimilars offers valuable insights. Dr. Subhadeep D Sinha, how relevant is it to the Indian scenario? Do the safety and efficacy remain consistent across both countries? Should we add a section specifically addressing the regulatory framework for biosimilar approval and interchangeability in India?
Interchangeability as a regulatory requirement involves clinical studies where comparability between a biosimilar (test) and the innovator (reference) product is assessed through a crossover from the test to the reference and then back to the test in patients. This requirement is specific to the USA and is mandated by the FDA for clinical evidence in addition to chemical and biological characterization.
In other regulatory regions, including Europe and India, such studies are not mandated by regulations. In Europe, medical switching between a biosimilar and the reference innovator is typically at the discretion of the prescriber, often in consultation with local regulators.
For India, while the safety and efficacy of biosimilars are ensured through stringent regulatory frameworks, the approach to interchangeability is more aligned with global practices outside the USA. Therefore, it would be beneficial to include a section in the article addressing the specific regulatory framework for biosimilar approval and interchangeability in India to provide context and relevance for the Indian audience.
Do you think it would be helpful to clarify how pharmacy substitution practices work for biosimilars in India, compared to the US model?
In India, there are no specific restrictions on the substitution of biosimilars. However, the use of biosimilars is primarily driven by clinical practitioners based on local availability and their clinical discretion. Unlike the US model, where specific interchangeability requirements are mandated by the FDA, the decision to use a biosimilar in India is more flexible and left to the judgment of healthcare providers.
The FDA article talks about the impact of biosimilars on patient treatment days in the US. Would it be interesting to see if we can find similar data on biosimilar usage in India?
The FDA article highlights that widespread usage of biosimilars in the US has not led to any increased safety concerns or reduced efficacy, and it quantifies this through patient treatment days. In India, such specific data is not available from the regulatory system. However, it might be possible to derive similar insights from market research databases to understand prescription patterns and their quantum. This endeavor would require significant collaborative efforts to compile and analyze the necessary data.
While the article mentions cost reduction as a potential benefit, it focuses on the US market. Do you think we should add a section specifically discussing the potential cost savings associated with biosimilars in India, considering factors like insurance coverage here?
Yes, it is very much required. The use of biosimilars is primarily in chronic therapies such as oncology, immunological, and arthritic diseases, and occasionally in acute illnesses. These treatments are very expensive and can significantly strain a patient’s and their family’s finances. A large part of these expenses is due to the high cost of biological therapies. Biosimilars are developed and priced to provide significant reductions in therapy costs. In India, insurance coverage in the private healthcare sector is minimal. Therefore, the use of biosimilars can help mitigate the financial risks for patients due to the limited insurance coverage, making these therapies more accessible and affordable.
Are there any specific concerns or challenges we should be aware of regarding wider biosimilar adoption in the Indian market?
The challenges in wider biosimilar adoption in India are primarily related to prescriber acceptance and awareness. Despite widespread adoption by their Western counterparts, Indian prescribers often exhibit hesitance due to the critical nature of illnesses treated with biosimilars, particularly cancers, where high-quality medicines are essential for patient outcomes. This hesitation is partly due to a lack of awareness and mistrust in Indian biosimilars.
Another significant challenge is the inadequacy of regulatory guidelines for biosimilar development in India. The data generated for Indian regulatory approvals may not meet global standards, necessitating additional studies for global submissions. This requirement prolongs the acceptance and approval process in highly regulated markets, hindering the global acceptance of Indian biosimilars.
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