Indian biosimilar market is moving beyond launch-centric phase: Sheetal Sapale

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“The Indian biosimilar market is clearly moving beyond a launch-centric phase into one where depth of pipeline and therapeutic diversification define long-term competitiveness,” said Sheetal Sapale, Vice President – Commercial at Pharmarack Technologies. “Companies that have already established a commercial foothold are now reinvesting into development pipelines and exploratory programmes, while others are strengthening their portfolios to prepare for scale and global relevance.”

In a webinar titled ‘Budget 2026: The Inflection Point for India Pharma’s Next Growth Cycle’, she said that India’s biosimilar sector is rapidly evolving from first-wave launches into a multi-therapy growth engine. Biocon Ltd and Intas Pharmaceuticals, with multiple biosimilars already commercialised across autoimmune, oncology, metabolic, and supportive care segments, are reinforcing their leadership through deeper pipelines and selective exploration in complex biologics. Zydus Lifesciences, following oncology launches such as nivolumab, is accelerating development across autoimmune and metabolic pathways, signalling a broader biologics strategy beyond initial wins.

Companies such as Enzene Biosciences (Alkem), Cadila Healthcare, and Hetero Drugs are building on early launch successes—particularly in adalimumab and growth factors—by expanding into additional monoclonal antibodies and supportive biologics like G-CSF and EPO. Meanwhile, large pharmaceutical players including Dr. Reddy’s Laboratories, Cipla, Lupin, Sun Pharma, and Panacea Biotec are transitioning from early launches or stated interests into more robust development pipelines spanning TNF and IL inhibitors, oncology molecules, and essential support biologics. Collectively, these trends highlight a decisive move away from single-product strategies, positioning India as a globally competitive hub for biosimilar innovation, scale, and long-term therapeutic diversification.