12:00 AM
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Mar 18, 2013
 |  BioCentury  |  Product Development

Bettering China's biosimilars

Henlius, Innovent represent new breed of biosimilars companies in China

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 sequence as the innovator biologic in their manufacture, according to Innovent co-founder, President and CEO Michael Yu.

As a result, these new versions of biologics "have lower activities than the original products and their overall quality does not comply with international standards" for biosimilars, he told BioCentury.

He also said most biologic manufacturing facilities in China do not comply with international GMP standards and thus produce versions of biologics that are not as pure as the original products.

Companies in China that market copies of innovator biologics know how regulators in the U.S. and EU define biosimilars and know that their products do not meet that definition, said Scott Liu, co-founder and CEO of Henlius.

Liu added that these products cannot be marketed as biosimilars in China because SFDA has not yet created a biosimilars pathway. Instead, the products follow the same regulatory pathway as novel biologics, he said.

However, because the copycats have the same generic names as the innovator products and are approved to treat many of the same indications, they can be mistakenly perceived as biosimilars, said Greg Scott, founder and president of consultancy ChinaBio...

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