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.