Bettering China's biosimilars

While many homegrown biologics marketed in China could be perceived as biosimilars, most are unlikely to meet international standards and are not marketed as such in China. But with an uptick in returnees and VC investment, and improvement in manufacturing infrastructure, Chinese companies such as Henlius Biotech Co. Ltd. and Innovent Biologics Inc. are aiming to develop true biosimilars that could compete in the global market.

Current regulations in the EU and U.S. require a biosimilar to have the same amino acid sequence as the innovator biologic, and glycosylation patterns and other structural features that are highly similar, so that the two products closely match in terms of efficacy and safety...