Can India lead the world in affordable biosimilars?

This opinion piece, authored by Iqra Ather and K. Madan Gopal from the National Health Systems Resource Centre (NHSRC), explores the promise of biosimilars in making life-saving treatments — such as those for cancer, diabetes, or autoimmune diseases — accessible to all. As global healthcare systems seek cost-effective solutions, the authors examine whether India can emerge as a leading hub for affordable biosimilar production.

Imagine if life-saving treatments for cancer, diabetes, or autoimmune diseases were available to everyone, everywhere — regardless of income. That’s the promise of biosimilars: affordable versions of complex biologic drugs. As global healthcare systems look for cost-effective solutions, India is quietly building the capacity to become a global hub for biosimilar production. But will we rise to the challenge?

What are biosimilars and why do they matter?

Biologics are advanced medicines made from living cells. They’ve revolutionised treatment — but come at steep prices. Biosimilars are not generic drugs in the usual sense; they are near-identical copies of biologics whose patents have expired, requiring rigorous testing to prove similarity, safety, and efficacy.

With biologics worth nearly $390 billion globally, and many of them nearing patent expiration by 2030, the biosimilar market is booming. India, already a leader in generic medicines, has the infrastructure, talent, and regulatory push to step up. But the road isn’t without its bumps. 

India’s advantages: The potential is real

India’s biopharmaceutical industry is already showing what’s possible. Companies like Biocon, Zydus Cadila , and Dr. Reddy’s have launched biosimilars globally. Biocon’s Semglee, an insulin biosimilar, became the first from India to receive interchangeable status from the US FDA — a milestone not just for the company, but for the country.

Add to that:

• Skilled manpower: India trains thousands in life sciences and pharmacy every year.

• Cost advantage: Production costs are lower, making drugs more affordable.

• Regulatory progress: With bodies like CDSCO streamlining biosimilar approval guidelines, India is increasingly aligned with global norms. 

Yet, these strengths can only take us so far without addressing systemic bottlenecks.

What’s holding us back?

Despite global recognition, India’s biosimilar sector faces challenges in manufacturing scale, global credibility, and policy clarity.

• Regulatory complexity: Indian biosimilars still struggle with non-harmonised international requirements. A product approved in India often needs additional trials for the US or EU.

• Data integrity and quality issues: Recent FDA warnings to Indian manufacturers highlight the need for robust quality control and compliance systems.

• Insufficient R&D ecosystem: Biosimilars require not just manufacturing but advanced analytical capabilities, clinical testing, and tech transfer pipelines — areas needing urgent investment.

Moreover, cross-sectoral coordination between research institutes, biotech startups, regulators, and pharma players is currently fragmented.

What will it take for India to lead?

If India wants to lead the biosimilar revolution; not just participate — it needs more than ambition. It needs a focused gameplan, one that combines smart regulation with scientific readiness. Here’s what that could look like:

• Make regulation an enabler, not a roadblock
  Streamline biosimilar approvals with science-backed fast tracks. Align with global norms — what works for the EU or US shouldn’t require a repeat trial here.

• Invest where it matters
  Build and scale biologics clusters — not just in metros, but in Tier-II cities. Strengthen cold chains, digital tracking, and export logistics. Let every new lab double as a training ground.

• Skilling for the science of tomorrow
  Biosimilars need talent that understands both biology and regulation. From pharmacovigilance to digital bioprocessing, we need to skill and reskill thousands to meet global expectations.

• Build bridges, not silos
  Work closely with global regulators like EMA and FDA. Encourage research collaborations, joint reviews, and mutual recognition. Indian science doesn’t need to work in isolation.

This isn’t about favouring big pharma. It’s about creating an ecosystem where startups, researchers, and manufacturers can collaborate and thrive.

From generic powerhouse to biologics leader

India already produces over 60% of the world’s vaccines. Biosimilars could be the next big leap not just for export numbers, but for equitable, affordable healthcare globally.

If we act now, projections suggest India could meet half the world’s biosimilar demand by 2040. That’s not just a market opportunity; it’s a moral one. Countries like South Korea and Singapore have built thriving biotherapeutics sectors through strategic policies, strong R&D investments, and international partnerships. 

The Figures 3, 4 and 5 presents three illustrative case studies — Biocon in India, Samsung Biologics in South Korea, and Celltrion in South Korea — demonstrating how targeted patent-cliff strategies, robust infrastructure, and global collaborations can drive rapid growth. Beyond operational excellence, these examples highlight the strategic importance of building end-to-end capabilities — from R&D to regulatory readiness and export facilitation. The scale and speed achieved by these firms were not solely the result of internal efficiencies, but of broader ecosystem support, including fast-track approvals, coordinated policy push, and sustained state backing. Notably, the South Korean examples underscore how clear regulatory timelines and generous fiscal incentives can catalyse industrial scale-up, while Biocon’s trajectory reflects how long-term institutional investments and scientific leadership shape global competitiveness. Together, they demonstrate that when government policy, industrial strategy, and research priorities are aligned, biotherapeutics capacity can grow rapidly and resiliently.

By adapting these lessons, India can refine its policy frameworks, strengthen its innovation pipelines, and fast-track approval processes to establish a leadership position in global biotherapeutics. 

The bottom line

India has the science, the talent, and the manufacturing muscle. But without focused investment, stronger regulation, and collaborative infrastructure, the window of opportunity could close fast.