India’s next pharma revolution: Crushing patent games to dominate the $200B biosimilars market

Today, biologics dominate treatment for chronic diseases like cancer and diabetes. However, the biologics treatment is very costly, and generally unaffordable. Reason, biologics medicines have previously been under patent protection, and as result, subject to payment of huge royalties. Generic drugs being produced in India and being made available to masses in India and all over the globe, were also under patent protection at one point of time. Later, once patent expired, pharmaceutical producers were able to produce these medicines, free of payment of royalties, what we call generic medicines.

But, many of the biological medicines have gone off-patent. Now, India faces a new challenge: ensuring these biological life-saving drugs, are also produced free from patents and royalty. These, new types of medicines, can help us treat most deadly diseases, and these treatments shouldn’t remain a luxury of rich.

Biosimilars – near-identical, cost-effective versions of biologics – offer a solution. Yet, their potential is stifled by patent evergreening, regulatory fragmentation, and gaps in self-reliance. By patent ever-greening we mean, extending patent protection beyond their expiry date. It so happens, when patent holder is able to get the same drug (in this case, biologics) patented, after the original patent gets expired. It’s notable here that, Section 3(d) of the Indian Patents Act, 1970, generally prevents patents for the mere discovery of a new form of a known substance that doesn't enhance its known efficacy, or for the mere discovery of new properties or uses of a known substance, or for the mere use of a known process.

This section is designed to prevent "evergreening" of patents by allowing minor modifications of known substances to be patented repeatedly

The Council for International Economic Understanding, a Think Tank, recently published a report titled ‘Advancing Affordable Healthcare – The Transformative Potential of Biosimilars in India’, where it mentioned that “Biosimilars represent a crucial advancement in making treatments for chronic diseases like cancer and autoimmune conditions more affordable in India, where the burden of such illnesses is escalating”. The report also mentioned, India has emerged as a global leader, with over 98 biosimilars already approved domestically.

The Urgency of Affordable Biologics
Biologics, though revolutionary, are prohibitively expensive. A single dose of trastuzumab, a breast cancer drug, costs over Rs. 1 lakh in India, pushing families into debt.

Biosimilars, priced 50-75% lower, have already shown transformative impact. For instance, biosimilar rituximab increased affordability for lymphoma patients from 35% in 2010 to 95% by 2020. With 118 biologics set to lose patent protection globally by 2034, India’s cost-efficient manufacturing, offers us a unique opportunity to produce these biosimilars, at the most affordable prices, made in India, for the world. It’s notable that whereas, biosimilar development costs $10 million to $20 million, the same would cost $100 to $200 million in the west. This gives us an opportunity to position India as global hub for biosimilars; and make affordable biosimilars for patients not only in India but even globally, and lead the world in biosimilars also, as we do in case of generic drugs.

But, the problem is that, only 10% of these off-patent biologics currently have biosimilar development plans. This scenario signals a critical opportunity for India to fill the void.  

Patent Evergreening: A Barrier to Progress
The promise of biosimilars is undermined by patent evergreening, where minor modifications – like tweaking drug formulations or delivery mechanisms – extend monopolies. Roche’s prolonged litigation over trastuzumab biosimilars delayed affordable alternatives for years, while Merck’s patent strategies around cetuximab exemplify how secondary patents stifle competition. Despite Section 3(d) of India’s Patents Act, which rejects patents that lack “enhancement of the known efficacy”, 72% of pharma patents granted between 2009–2016 were secondary. This simply means, ever greening of patents, and requires serious enquiry.

We need to understand that such tactics, not only undermine our IPR, which had been designed to serve the cause of public health, and therefore humanity. Ever greening of patents, inflate drug prices, exacerbating a healthcare system where 32-39 million Indians fall into poverty annually due to medical costs.  

Regulatory Hurdles and the Path Forward
India’s 2012 biosimilar guidelines, revised in 2016, were pioneering but now lag behind global standards. The World Health Organization’s 2022 updates emphasize streamlined approvals, yet India’s process remains fragmented. At present manufacturers have to obtain separate clearances from the the Central Drugs Standard Control Organisation(CDSCO), (Ministry of Health) and Review Committee on Genetic Manipulation( RCGM) (Department of Biotechnology). This delays market entry for Biosimilars. A unified digital portal could eliminate these bureaucratic bottlenecks. Additionally, import reliance for raw materials undermines cost efficiency. Strengthening domestic production under initiatives like Make in India and the National Biopharma Mission is critical to achieving self-reliance.  

India Must Take Leadership
There is a huge opportunity waiting for India in the field of Biosimilars. To capitalize on this moment, India must act decisively:  
1. Revise Biosimilar Guidelines: Align India’s 2016 Biosimilar framework with WHO standards, incorporating periodic reviews to stay ahead of global trends. A draft update, slated for August 2025, must prioritize transparency and faster approvals.  
2. Curb Evergreening: Strengthen patent examination to enforce Section 3(d) rigorously. Specialized IP benches are one way to achieve expedited dispute resolution and deter frivolous claims.  
3. Boost Domestic Capacity: Redirect National Biopharma Mission funds toward R&D and infrastructure for biosimilars, reducing import dependency.  
4. Leverage Public Procurement: Integrate biosimilars into Ayushman Bharat and bulk purchasing schemes to ensure demand and affordability.  

A Vision of Equitable Healthcare
India’s biosimilar ambition is not just economic – it is a moral obligation. With 63% of deaths linked to chronic diseases and out-of-pocket expenses dominating healthcare spending, affordable biologics are essential to prevent families from sacrificing education, livelihoods, or dignity for treatment. By streamlining regulations, defending competition, and investing in self-reliance, India can replicate its generics success in biosimilars.

The roadmap is clear: revise guidelines, unify approvals, and prioritize domestic innovation. By doing so, India will not only solidify its role as the pharmacy of the world but also ensure that breakthroughs in medicine reach those who need them most – proving, once again, that equity and progress can go hand in hand. 

Views are personal. The author is National Co-Convener of Swadeshi Jagaran Manch (SJM)  and ex-professor, PGDAV College, University of Delhi