Trade groups weigh in on China FDA's biosimilars guidance

The Biotechnology Industry Organization (BIO) and the R&D-based Pharmaceutical Association in China (RDPAC) each asked the China Food and Drug Administration (CFDA) to modify and clarify its biosimilars draft guidance. CFDA issued draft guidance this fall outlining principles for developing biosimilars of biologics already approved in China (see BioCentury Extra, Nov. 11).

The guidance allows for additional assessment of a biosimilar candidate if a comparability study shows differences between the candidate and its reference product. BIO and RDPAC said if discrepancies are observed at the chemistry, manufacturing and controls (CMC) level and the preclinical level, the candidate should not be considered a biosimilar. RDPAC further suggested that if a candidate is found to be unsuitable as a biosimilar, it should be allowed to switch to new drug development and registration pathways directly. ...