Can Indian biosimilars and generics restate accessibility in global underserved markets?

Pharmacy of the world, a name that India has earned through the provision of low-cost, quality generics to patients geographically. India now produces close to 20 per cent of the world’s generic medicines and more than 60 per cent of the demand for vaccines worldwide. The global healthcare landscape is evolving with patients no longer asking for affordable drugs alone, but are seeking innovative biologics, biosimilars, and personalized medicines.

The conversation is no longer about India retaining the position as one of the world’s largest generics suppliers; it is about establishing leadership with nextgeneration therapies and redefining access to underserved therapeutic categories.

Generics: The bedrock of access

Generic medicines have revolutionized the affordability of healthcare globally. India’s scale of production, regulatory capacity, and low-cost supply chains supported the global spread of ARVs for HIV/AIDS in Africa, oncology medicines in Latin America, and critical antibiotics in Asia as a few examples. 

But the generics business is coming of age. Price erosion, patent cliffs levelling out, and increasing regulatory pressures are compressing margins. India needs to approach generics not as the end game but as the springboard for innovation to continue playing its role as the pharmacy of the world.

Biosimilars: The next frontier of access

Treatments using biologics for oncology, autoimmune disorders, and orphan diseases amount to almost half of the worldwide pharmaceutical market in value. At these prices most low- and middle-income nations get excluded. Biosimilars, the generics equivalent for biologics, do provide a great opportunity to expand access across the board. India is already a strong player in this sector; it already has over 100 approved biosimilars and has established global supply capacity with players such as Biocon, Dr. Reddy’s, Intas, etc., With cost savings of 20–40 per cent relative to innovator biologics, Indian biosimilars have the potential to repeat the generics revolution on an even larger scale. But there are challenges. The manufacture of biosimilars requires advanced biologics manufacturing, clinical comparability trials, and credibility with regulators in the US and EU. To lead the way here, India will need to invest in advanced biologics facilities, develop scientific sophistication in cell line development, and align regulatory norms with the most stringent global norms.

Precision medicine: Beyond “one-size-fits-all”

The future of medicine is in personalizing treatments to the patient profile—genomics, proteomics, and AI-driven information. Precision medicine is no longer limited to academic laboratories; it’s about bringing commercial pipelines and treatment guidelines globally to India, thereby presenting this as both a challenge and an opportunity.

The task is obvious: advanced R&D capacities, large-scale biobanking, and assured data governance remain embryonic. The potential is larger; India has unparalleled genetic diversity, an accelerant in its digitizing healthcare environment, and computational science cost advantages. With the combination of AI and biopharma production and clinical studies, India can bypass into

1.Strong regulatory ecosystems – Need for establishing strong regulatory ecosystem (like USFDA, EMA, PMDA) through voluntary compliance, quicker DMF/CEP submissions, and implementation of global GMP/GDP best practices. Regulatory trust will be the “currency” of biosimilar and biologic acceptance. 

2. Invest in biologics infrastructure – Support public–private partnerships and incentives for cell culture facilities, fermentation units, and bioanalytical laboratories. The Indian PLI schemes should move toward complex biologics as well. 

3. Academia–industry linkages – Focus more on translational research centers where all parties like universities, startups, and the pharma industry work together on biosimilars, monoclonal antibodies, and even on gene therapy. 

4. Leverage AI and digital health – Utilize AI for predictive compliance, supply-chain optimization, and precision medicine R&D. India’s IT backbone naturally enhances its digital bio-pharma integration capabilities. 

5. Develop global market access – In addition to the US and the EU, we need to look at Africa, Southeast Asia, and Latin America. Countries where demand for affordable biosimilars and precision therapies is escalating. It will be important to partner with local distributors, regulators, and governments. 

6. Maintain talent development – Specialised programmes in manufacturing of biologics, regulatory affairs and bioinformatics need to be introduced in universities and also scaled up to ensure the workforce is future ready.

A new definition of accessibility

While the early writings in the story of India’s pharmaceutical journey was that of making generics affordable, the next chapter should be the one to make innovative medicines available. We don’t just need low priced medicines, we need access to therapies that can alter the course of autoimmune conditions, rare diseases & cancer. By building on its established strengths India can redefine medicine access for billions. It will not only solidify our position as the pharmacy of the world, but also advance our position to become a global health innovator.