The economics of translating a biosimilar from lab to market in India

This study aims to establish a cost basis for biologics manufacturers and policymakers by quantifying the price and time required to bring a biosimilar from the lab to market. For efficient implementation of a cost‐based policy, especially for life‐saving medicines like biosimilars, it is imperative to establish a benchmark for the cost involved in biosimilar development. In this holistic and multiple‐case study, stage‐wise cost estimates of biosimilar development were obtained for microbial and mammalian systems. The investigation of six biopharmaceutical companies based in India concluded that biosimilar development through the microbial system costs ∼18 million USD and ∼21 million USD for the mammalian system. Additionally, 45–50 million USD is required as a one‐time capital investment. Further, US/EU authorization can cost ∼25 million USD per product. Clinical studies are the most expensive and account for 60%–70% of total development cost. The presented information can serve as a basis for implementing cost‐based pricing in countries like India and reimbursement policies for biosimilars under Medicare Part B in the United States. The affordability of biosimilars raises concerns for global health agencies, including the World Health Organization (WHO). To implement effective cost‐based pricing, policymakers need a clear cost reference through quantifying price and time. Research indicates that developing biosimilars in India requires significant investment, approximately 65–70 million USD, and nearly a decade from inception to post‐market studies. These findings can inform reimbursement policies for biosimilars in developed countries with appropriate modifications.