The Center for Drug Evaluation (the “CDE”) under the China Food and Drug Administration published final biosimilars guidance on February 28 with immediate effect. Officially titled the Technical Guideline for the Research, Development and Evaluation of Biosimilars (“Tentative”), the Guideline aims to address clinical needs for biologics in China by improving the accessibility and affordability of novel products. Biopharmaceutical companies will likely benefit from the Guideline, as it provides an alternative option for launching biologics in China.

Like the draft issued in November 2014 (please refer to our Alert on the draft dated November 5, 2014), the final Guideline sets forth basic principles for the technical review of biosimilars, the criteria for establishing biosimilarity, and the conditions under which extrapolations of indications are permissible. The Guideline clarifies some outstanding questions, such as the approval pathway for biosimilars relative to novel biologics, and adopts less stringent requirements, for example in the definition of a biosimilar and its reference product.

Key differences between the final Guideline and its previous draft are summarized in the following table.

Click here to view the table.

Currently, it can take at least 5-6 years for companies to launch innovative biologics in China. While biosimilars are subject to the same approval pathway as novel biologics with a set of different technical review criteria, it remains unclear if the time to market for biosimilars will be substantially reduced. Companies interested in developing biosimilars are advised to carefully review the Guideline and evaluate their product development strategies.