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Kale, Dinar and Niosi, Jorge
(2017).
DOI: https://doi.org/10.1080/09537325.2016.1274391
Abstract
This special issue of Technology Analysis & Strategic Management brings together a collection of recent empirical and conceptual insights on the emergence of biosimilar drugs, focusing on key developments that are significant for industrial dynamics, evolution of regulatory policies and affordable healthcare. Biosimilars are imitative versions of biologicals - a therapeutic drug category comprising large complex molecules. Traditionally, biologicals have been developed to address the most challenging illnesses such as cancer, autoimmune diseases, diabetes, growth hormone deficiency and inflammation. The extraordinary interest in biosimilars is driven by blockbuster biological products going off-patents, and evolving regulatory frameworks are paving the way for their entry into health care markets. This has created a significant opportunity for the pharma-biotech industry and government policy-makers to provide affordable treatments in advanced as well as developing countries. The promise of biosimilars as significant market opportunity is being heralded in an era of growing aging population and increasing healthcare costs.