China Issues Biosimilar Guidelines Draft

China Issues Biosimilar Guidelines Draft

Bahati 3 December 2014

A long-awaited set of guidelines for a billion-dollar market.


After years of waiting, Chinese biosimilar makers will soon have a set of guidelines to follow.

This post on Thomson Reuters Life Sciences Connect news blog (HERE) outlines the  industry’s reaction to the draft biosimilar guidelines.

The global biologics market is experiencing a golden age over the current decade. As drug development progresses, it’s time for biopharmaceutical companies to start reaping its rewards. The market is expected to grow more than 80 percent from $138 billion in 2010 to $253 billion by 2020, according to Sandoz international GmbH. And $2 billion of this will be coming from biosimilar products.

After researching, drafting and talking with Chinese biopharmaceutical executives, the Centre for Drug Evaluation (CDE) of the Chinese Food and Drug Administration (CFDA) finally released the Draft Technical Guideline for the Research, Development and Evaluation of Biosimilars on October 29. It was open for public opinion until Nov. 29.

“Biological drugs have shown obvious clinical advantages in treating many fatal diseases,” says the Chinese-language preface to the guidelines. “With patent expiry and biotechnology development, biosimilars have attracted more and more attention to improve availability and accessibility (of drugs).”

For the time being, this rapidly growing category of drugs are treated as new drugs in China and have to go through similar pathways of approvals, which involve expensive and lengthy clinical trials. But the release of the draft guiltiness suggests that the country is maybe considering creating a separate approval pathway.

In the draft, the CDE defines biosimilars as “therapeutic biological products that are similar to the originator drugs already approved by the CFDA in terms of quality, safety and efficacy.”

The definitions are similar to those used by the European Union, which has led the way in regulating biosimilars. Other countries around the world, including Australia and South Korea, have developed biosimilar guidelines that generally follow the European model.

The guideline offers guidance on choosing reference drugs, doing pre-clinical studies and conducting comparative clinical trials. It also sets forth the basic principles for the technical review of biosimilars: the comparison principle, the stepwise approach principle, the consistency principle, and the biosimilarity evaluation principle.

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