Pune: Pune, long known for its dominance in vaccine manufacturing and life-sciences research, is steadily emerging as a key hub for advanced biologics and biosimilars, complex, high-value drugs used to treat cancers, autoimmune disorders, osteoporosis and retinal diseases.With the Centre’s latest budgetary push to position India as a global biopharma powerhouse, experts say established clusters like Pune will now be judged less by legacy strength and more by their ability to rapidly scale biomanufacturing infrastructure, specialised talent and globally aligned regulatory systems.Underlining the importance of biologic medicines at affordable costs to longevity and quality of life, Union finance minister Nirmala Sitharaman on Sunday announced Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation) with a total outlay of Rs10,000 crore over the next five years.The programme is designed to develop India into a global biopharmaceutical manufacturing hub by building a strong and self-reliant ecosystem for the domestic production of biologics and biosimilars.India currently contributes an estimated 3-4% of global biosimilar production, a share that could expand sharply if manufacturing capacity, quality systems and export readiness improve in tandem.“Pune’s biopharma ecosystem is increasingly moving beyond vaccines into high-value biologics such as monoclonal antibodies, therapeutic proteins and recombinant protein-based drugs, areas that are central to India’s global biopharma ambitions as envisioned in the Union Budget,” said senior biopharma expert Dr Rajeev Dhere.Dr Dhere pointed to companies such as Serum Institute of India (SII), Lupin and Gennova Biopharmaceuticals as key Pune-based players with the scientific depth and manufacturing scale needed to compete globally.“Monoclonal antibodies, especially disease-targeted therapies used in cancers and infectious diseases, are among the most expensive drugs in the world. But they also have a truly global market,” Dr Dhere said.Serum Institute has significantly diversified beyond vaccines, with a strong pipeline in monoclonal antibodies and recombinant protein therapeutics.“Our dengue monoclonal antibody programme has reached advanced clinical stages, including phase-3 trials, while the company is also developing monoclonal antibodies for other diseases through international collaborations,” said Dr Umesh Shaligram, executive director, SII.“Serum’s rabies monoclonal antibody is already in clinical use, and an improved next-generation version is under development. Work is underway on generic monoclonal antibodies and anti-RSV therapies,” Dr Shaligram said.With Pune hosting firms that have global regulatory experience, international partnerships and the ability to scale up both products and production, the city is well placed to play a decisive role in helping India emerge as a global hub for biologics and biosimilars, provided investments in infrastructure and skills keep pace with ambition.Dr Cyrus Karkaria, who heads Lupin’s biotechnology division and oversees the development of the company’s global biosimilars portfolio, said Pune has the potential to play a pivotal role in India’s biopharma growth, given the presence of strong academic institutions and companies with deep biotechnology expertise and manufacturing infrastructure.He emphasised that success would hinge on the right industry-academia collaborations and a more cooperative, predictable regulatory environment.“There have been biopharma manufacturing initiatives in the past, but the application processes were often ambiguous. If procedures are streamlined and clarity improves, it could significantly accelerate growth,” Dr Karkaria said.Local biosimilars in Pune address a wide array of conditions: from arthritis (Adalimumab) and osteoporosis (Teriparatide, Denosumab) to oncology (Bevacizumab, Cetuximab) and ocular diseases (Ranibizumab), indicating a product portfolio that spans major therapeutic domains.“I see the Union Budget 2026 as a very strategic attempt to bridge India’s inherent strengths with areas where we still need to build capacity. With the possibility of a significant outflow of highly skilled professionals from the United States in the coming years, this is the right moment to create meaningful opportunities at home. If we do this well, it can lead to a real orbit change for the country. Initiatives such as university townships, education excellence zones, and the AYUSH hub linked with the WHO reflect this long-term thinking,” said Bhushan Patwardhan, national research professor-Ayush.What are biologics and biosimilars?Biologics are complex medicines made from living cells, such as antibodies or proteins, that precisely target disease pathways to treat conditions like cancer, autoimmune disorders and infections.Biosimilars are highly similar versions of approved biologics that deliver the same clinical benefits at lower cost, improving access to life-saving treatments for chronic and life-threatening diseases.The new beckoningIndia’s pharma sector, already the world’s third-largest by volume, is rapidly pivoting from small-molecule generics to complex biologics and biosimilars.The biologics market itself is substantial: as of 2025, the Indian biologics market was valued at an estimated USD 13.3 billion and is forecast to almost double by 2034.Nationwide, over 70 biosimilar products have already received approval from Indian regulators, spanning therapeutic categories such as monoclonal antibodies, growth factors, insulins and recombinant proteins.
