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.
The first step in developing a biosimilar involves rigorous analyses of the innovator product to identify its amino acid structure, define the range of its structural variations, and determine which variations could affect efficacy and safety. Those results provide goalposts that guide the design and manufacture of a biologic that closely matches the original.
Products marketed in China that might be perceived as biosimilars were not developed with such rigorous upfront analyses and might not even use the same recombinant DNA