Millions of Indian households struggle with high healthcare costs, with an estimated 32–39 million people falling into poverty annually due to medical expenses. Many are forced to sell property or pawn family jewellery to afford life-saving treatments. With limited insurance coverage adding to the financial burden, there is an urgent need for cost-effective alternatives to expensive treatments.

Biologics, which have revolutionized treatments for cancer, autoimmune disorders, and rare diseases, remain unaffordable for most Indians. However, biosimilars, which are near-identical and significantly cheaper alternatives, present a game-changing opportunity to reduce treatment costs by 50–75%.

India’s Role in Biosimilar Production

India has emerged as a global leader in biosimilar production. Recognizing the potential of biosimilars, India introduced Biosimilar Guidelines in 2012, later revised in 2016, to regulate and encourage market entry.

To date, nearly 100 biosimilars have been approved in India. However, their widespread adoption faces several challenges, primarily due to patent evergreening by multinational pharmaceutical companies. These firms extend exclusivity through secondary patents and litigation, delaying the entry of affordable biosimilars into the market.

Challenges Hindering Biosimilar Adoption

1. Patent Evergreening and Legal Barriers

   • Multinational companies file secondary patents, preventing biosimilar market entry.
   • Prolonged legal battles discourage domestic manufacturers from investing in biosimilar research.

2. Regulatory Hurdles and Market Access

   • India’s regulatory framework for biosimilars is still evolving, leading to long approval timelines.
   • Lack of clarity in pricing and reimbursement policies affects adoption in public health programs.

3. Awareness and Trust Issues

   • Physician reluctance and limited patient awareness about biosimilars hinder widespread usage.
   • Misinformation about efficacy and safety needs to be addressed through clinical education.

Solutions to Boost Biosimilar Adoption

A multi-pronged strategy is necessary to ensure that biosimilars can effectively lower healthcare costs and improve accessibility:

1. Differential Pricing and Bulk Procurement

   • Government-led bulk procurement can drive affordability, similar to generic medicines.
   • Programs like Ayushman Bharat can integrate biosimilars to expand access to low-income patients.

2. Proactive Competition Regulation

   • The Competition Commission of India (CCI) must monitor and prevent anti-competitive practices by multinational firms.
   • Enforcing stringent patent expiration policies will allow timely biosimilar market entry.

3. Streamlined Regulatory Approvals

   • The Drugs Controller General of India (DCGI) should expedite approvals to encourage domestic manufacturing.
   • Fast-track approval mechanisms will reduce delays and encourage investment in biosimilar production.

4. Stronger Local Manufacturing and R&D Support

   • India’s pharmaceutical industry, which already supplies 40% of US generic drugs, should focus on biosimilar innovation.
   • Government incentives can promote local manufacturing, reducing dependency on imported biologics.

The Global Opportunity for India

India’s generic pharmaceutical exports saved the US healthcare system Rs. 19,09,242 crore (US$ 219 billion) in 2022. A similar strategy for biosimilars can transform global healthcare affordability. If regulatory frameworks are strengthened, India can become a global hub for biosimilar production, enhancing both domestic healthcare access and export potential.

Conclusion: A Stronger Push for Biosimilars

Biosimilars hold immense potential to reduce healthcare costs, prevent medical-induced poverty, and improve treatment accessibility. With the right policies, proactive regulations, and government initiatives, India can lead the biosimilar revolution, ensuring millions of patients receive affordable and life-saving medicines.

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