China launches its biosimilars process

The China Food and Drug Administration has issued draft guidance that lays down principles for developing biosimilars of biologics already approved in China, including products intended to be extrapolated to multiple indications.

According to an unofficial translation commissioned by BioCentury, the agency's Center for Drug Evaluation describes in its "Guidelines for R&D and Evaluation Techniques of Biosimilars" a stepwise approach in which the number of confirmatory tests escalates based on the developer's ability to demonstrate equivalence in pharmacological, non-clinical and clinical development. ...