On 31 October 2025, the Economic Times (ET) headline— “US biosimilar norms to keep local drug cos in good health” - quickly became one of the most discussed topics across India’s biopharmaceutical circles.

For India, which is transitioning from a global generics’ powerhouse to an emerging biologics player, this shift is more than regulatory news. It marks a critical moment that could either accelerate India’s biopharma ambitions or expose deep structural gaps.

What Has the US FDA Changed?

The ET report highlights a few key regulatory shifts:

• Reduced clinical trial requirements where scientifically justified
• A more predictable and transparent review pathway
• Lower development costs for manufacturers
• Quicker regulatory timelines

These changes significantly lower the barriers for biosimilar entry into the US – the world’s most lucrative biologics market.

For Indian companies, this means faster commercialization of assets previously slowed by cost, litigation, and development complexity.

Why These Norms Matter Deeply for India:

1. The Big Leap Beyond Generics

India’s pharmaceutical success has historically been built on small-molecule generics. Biosimilars represent the next step – complex, high-value biologics requiring advanced R&D, analytics, and precision manufacturing.

A friendlier US regulatory landscape can:

• Boost Indian biologics capabilities
• Enhance India’s scientific reputation
• Accelerate the transition from volume-based to value-based pharma exports

This is not incremental – it is transformational.

2. A Chance to Make Biologics Affordable – Globally and at Home

Indian biosimilars entering the US could push global prices downward, increasing patient access everywhere.

But the unanswered question remains:

Will India ensure the same benefits reach its own patients?

Historically, many biologics approved in India remain unaffordable. This opportunity must change that narrative.

3. Catalyst for Investment and Innovation

Success in the US market – considered the gold standard – often brings:

• Investor confidence
• International collaborations
• High-value licensing deals
• Technology transfer opportunities

If Indian firms reinvest this momentum into R&D, it can accelerate India’s shift toward a future where ‘innovated-in-India’ becomes as common as ‘made-in-India’.

4. Competitive Pressure on Originator Biologics

Lower-cost Indian biosimilars could challenge multinational biologics giants in their strongest market.

This may result in:

• Reduced prices
• Greater insurance coverage
• Wider patient access

It positions India as a meaningful global competitor – not just a contract manufacturer.

But the Red Flags Are Too Important to Ignore:

A) Biosimilars Are Not Generics – Quality Risks Are Heightened

Biologics demand:

• High-precision fermentation
• Immunogenicity evaluation
• Strong data integrity
• Robust GMP compliance

Any compliance slip-up in the US biosimilar space could severely damage India’s credibility.

This is a risk India cannot afford.

B) Patent Barriers Will Still Be Tough

Even with simplified norms, US biosimilar entry often faces:

• Patent thickets
• Secondary patents
• Litigation from innovator companies
• Market-access hurdles

Indian companies will need smarter IP and litigation strategies – not just efficient manufacturing.

C) India’s Own Ecosystem Needs Modernization

India must strengthen:

• Analytical labs for similarity assessments
• Biologics manufacturing clusters
• Cold-chain logistics
• CDSCO guidelines
• Pharmacovigilance systems

Without this, Indian biosimilars may flourish abroad while India continues lagging in domestic biologics availability and safety monitoring.

D) The Risk of Mission Drift

If export markets become the primary focus:

• Domestic patients may remain an afterthought
• Prices of biologics may not reduce meaningfully within India
• Public health benefits may fall behind corporate goals

Balancing global ambition with national responsibility is crucial.

What India Should Prioritize Now:

For Indian Pharma Companies

• Invest heavily in biologics R&D, analytics, and quality systems
• Strengthen data integrity and regulatory compliance
• Pursue strategic co-development partnerships
• Ensure domestic market access for biosimilars – not merely exports

For Indian Policymakers and Regulators

• Align CDSCO norms with US/EU biosimilar standards
• Build biotech clusters and offer strategic incentives
• Strengthen post-marketing surveillance
• Use public procurement to promote affordable biologics for Indian patients
• Encourage transparent pricing and competition

For Public Health Stakeholders

• Monitor domestic pricing of biosimilars
• Demand safety and immunogenicity transparency
• Advocate access for oncology, autoimmune, and rare disease treatments

A Defining Moment: Opportunity vs. Responsibility

India stands at a strategic crossroads.

If industry, policymakers, and regulators move in alignment, India can become a global biosimilar powerhouse - known for quality, affordability, and innovation.

If not, this moment may turn into yet another case where India enables global affordability while failing to deliver it domestically.

“The true test of India’s biosimilar advantage will be measured not in US approvals – but in whether Indian patients finally gain access to affordable biologics.”

Quick Takeaways:

• New US FDA biosimilar norms promise faster, less burdensome approval pathways.
• Indian companies like Biocon, Intas, and Dr. Reddy’s stand to gain significantly.
• But quality risks, patent barriers, and domestic-access concerns remain real.
• India must upgrade its biologics ecosystem—not just chase US profits.
• The real test: Will Indian patients benefit from this global opportunity?

Conclusion:

Closing Thought

The US FDA may have opened the door.
The world may be watching.
But only India can decide whether this moment becomes a turning point – or a missed opportunity.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.