Biologics And Biosimilars In India: The Imperative Shift With Insights From Ivf Treatments

India’s pharmaceutical industry is undergoing a strategic transition from small-molecule generics to complex biologics and biosimilars. Thisshift is driven by rising disease burdens, patent expiries, and the need for affordable advanced therapies. The pharmaceutical landscape is shifting toward biologics, with biosimilars offering cost-effective alternatives. India, traditionally strong in generics, is now transitioning into biologics to address rising healthcare costs and complex diseases. The global pharmaceutical industry is shifting from small-molecule drugs to biologics, with biosimilars emerging as cost-effective alternatives. India, historically dominant in generics, is now transitioning into biologics and biosimilars to address rising healthcare costs and complex disease burdens. This paper explores the necessity of this shift, focusing on In Vitro Fertilization (IVF) as a case study. IVF treatments rely heavily on biologics such as recombinant folliclestimulating hormone (rFSH), which significantly increase treatment costs. Evidence suggests that biosimilars offer comparable efficacy and safety while improving affordability, making them crucial for expanding access in India