Globalization of Biosimilars

Global uptake of Biosimilars has led to the adoption of distinct legal and regulatory frameworks in different countries. Thorough understanding of the marketing strategies, newer analytical characterization techniques and proper communication between regulatory authorities and manufacturers may help to bring a biosimilars more easily in the global market.

South Korea was the first country worldwide to approve biosimilar versions of etanercept according to international standards. Australia is the world’s first highly regulated market to allow pharmacy level substitution of a monoclonal antibody biosimilar for an originator. As of April 2016; 8 biosimilars have been approved in Japan, including the recent approved insulin glargine biosimilar. A recent report has shown that biosimilars in India have witnessed nearly 20% annual growth for the last financial year and now make up for about 2.5% of the overall biologics market.

Global uptake of Biosimilars has led to the adoption of distinct legal and regulatory frameworks in different countries. Thorough understanding of the marketing strategies, newer analytical characterization techniques and proper communication between regulatory authorities and manufacturers may help to bring a biosimilars more easily in the global market.

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