Study Offers Recommendations for China’s Biosimilar Regulations

A recently published paper in Frontiers in Pharmacology examines the regulatory framework surrounding biosimilars in China. The researchers noted that the regulatory system is not “clearly formed” and is ill suited to support the nearly 400 biosimilars in development in the country. The paper offers recommendations for improvement in several areas, including labeling.

According to Skylar Jeremias, “Regarding managing labels, it’s difficult to ensure that the macromolecular structural characteristics of biosimilars are consistent with the reference biologics. Labels should state that the product is a biosimilar and include comparative safety and efficacy data “to provide sufficient information for clinicians to make prescription decisions,” the authors wrote.”

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(Source: AJMC, March 16^th, 2023)