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US Biosimilar Overhaul: A Breakthrough Moment or a Strategic Test for Indian Pharma

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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.

India urgently needs a total overhaul and reform of its public healthcare system with a holistic approach – NRHM and RSBY are laudable initiatives.

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Over a period of time India had made significant improvement in various critical health indicators despite frugal public health spending by the government, which is just around 1 percent of GDP of the country. Such a low government spend towards public health takes India to the bottom 20 percent of countries of the world, in this respect.Overall progress of the country’s public healthcare system is, consequently, commensurate to the nation’s spending towards this vital sector. Only 35 percent of country’s population has now access to affordable modern medicines. Even many ASEAN countries are far ahead of India in their achievements towards public healthcare services. Such a grim scenario prompts us to understand the infrastructural and financial dimensions of the public healthcare system of the country to enable us to suggest appropriate reform measures for this sector to the policy makers.Very recently, the Prime Minister of the country Dr. Manmohan Singh indicated the intent of his government to raise the government spending towards public health to around 3 percent of the GDP. Health being a state subject in India, both the State and Central Governments will need to take their best foot forward towards this direction.

Fund Allocation towards public healthcare:

In the Eleventh Five Year Plan, the fund allocated by the government towards public healthcare shows a significant increase. The launch of ‘National Rural Health Mission (NRHM)’, which emphasizes community based monitoring along with decentralized planning and implementation augers well for the nation and vindicate, at least, the resolve of the government towards this direction.

Impediments to make NRHM a great success:

There are some serious infrastructural requirements to scale-up NRHM and make it successful. These are as follows:

1. More number of specialists, doctors, nurses and paramedics

2. More medical colleges and nursing schools

3. Less developed states should be financially and technologically helped to create public healthcare infrastructure

4. The student teacher ratio to be enhanced in specialties and super specialties from the current level of 1:1 to 2:1

5. Capacity building at the Medical colleges of the State Governments needs to be considered without further delay

6. The number of post-graduate medical seats needs to be increased, all over the country.

It is envisaged that all these critical steps, if taken with missionary zeal, will help increasing the number of post-graduate specialists from the existing level of 13000 to 18000, in the next five years.

Healthcare delivery:

Even if all these are achieved public healthcare delivery will still remain a key issue to achieve the country’s objective to provide affordable healthcare to all. The poor and marginalized people of our society must be covered adequately by the public healthcare system to the best extent possible.

Improving access:

To improve access to public healthcare services for the common man, India very badly needs structural reform of its public healthcare system, with a clear focus on preventive healthcare. This will in turn help the country reduce the burden of disease.

Healthcare financing:

In 2001 The Journal of Health Management in a study using National Health Accounts (NHA) as a tool of analysis reported:

“76 per cent of health sector revenues come from private sources, of which almost 50 per cent go to private providers and 21 per cent are spent on drugs. Further, 7 per cent of household out-of-pocket expenditure is used as non-drug expenditure for using government facilities for out-patient and in-patient treatment. This has important policy implications for the government.”

Along with increasing healthcare needs across all sections of the society, especially in the low income and the backward states, a very high percentage of out-of-pocket household expenditure towards healthcare, low public budgetary allocations and sluggish health outcomes, are calling for a robust healthcare financing model for the country.

Why is healthcare financing so important in a developing country like, India?

The largest number of poor population of the world resides in India. It has been reported that around three-fourth of over one billion population of the country earns less than two dollars a day. Coupled with poor hygienic condition this section of population is more prone to various illnesses, especially tropical diseases. India is one of those very few emerging economic super powers where around 90 percent of its population is not covered by any form of health care financing.

Under such circumstances, it has been widely reported that the poor very often will need to borrow money at a very high rate of interest or sell whatever small assets they own, further eroding their capability to come above the poverty line, in the longer term.

Thus to provide adequate health insurance cover to the marginalized section of the society including a large number of the rural population, the country is in a dire need to develop a workable and tailor-made healthcare financing model instead of pushing hard the existing ones. This tailor-made model should also include the domiciliary treatment, besides costs of hospitalization.

New healthcare reform process in India should include the healthcare system in its entirety with a holistic approach, starting from access to healthcare to its management and delivery, strengthened by a robust micro-healthcare financing system.

Rashtriya Swasthya Bima Yojna (RSBY): A good initiative by the government:

To partly address the above issue, on October 1, 2007 the Government of India announced a health insurance scheme for the Below Poverty Line (BPL) families in the unorganized sector called Rashtriya Swasthaya Bima Yojna (RSBY).

In RSBY, BPL families are entitled to more than 700 in-patient medical procedures with a cost of up to 30,000 rupees per annum for a nominal registration fee of 30 rupees. Pre-existing medical conditions are covered and there is no age limit. Coverage extends to the head of household, spouse and up to three dependents.

RSBY appears to benefit those people who need it the most. However, how effective will be the implementation of this scheme, still remains a key question. If implemented exactly the way the scheme was conceived, it has the potential to address the healthcare financing issue of around 28 percent of the population currently living below poverty line.

The initial response of RSBY has been reported to be good, with more than 46 lakh BPL families in eighteen States and Union Territories having been issued biometric smart cards, so far.

Conclusion:

To provide affordable healthcare services to all, India urgently needs a total overhaul and reform of its public healthcare system with a holistic approach. The steps so far taken by the government with the launch of NRHM and RSBY are laudable, but are these enough?

By Tapan Ray

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.