China’s Center for Drug Evaluation (CDE), which is part of CFDA (simplified Chinese: 国家食品药品监督管理局), issued draft guidance on 29 October 2014 outlining the principles for developing biosimilars of biologicals already approved in China. The draft guidance was released for a one-month consultation period, which ended on 29 November 2014 [1].

The draft guidance allows for additional assessment of a biosimilar candidate if a comparability study shows differences between the candidate and its reference product. However, both BIO and RDPAC have said that 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.

The draft guidance also establishes a step-by-step procedure in which ‘no or little difference’ in comparability testing found could allow subsequent comparability tests to be skipped. However, both organizations have recommended that if there are no discrepancies at the CMC and preclinical level, subsequent clinical comparability studies should include pharmacokinetic and pharmacodynamic studies. Both BIO and RDPAC also reiterated that biologicals approved as biosimilars should not be used as reference products.

Both groups also suggested that biosimilar applicants use clinical endpoints and study populations that are most sensitive to detecting clinically meaningful differences between the two products, particularly if the applicant seeks to extrapolate the data to additional indications. The draft guidance allows for extrapolation of indications, which will be considered on a case-by-case basis.

BIO has also recommended that CFDA consider the role of intellectual property protection for reference products in developing its biosimilars guidance. The trade group also noted that the CFDA’s guidance is generally consistent with biosimilars guidelines published by WHO, FDA and EMA.

CFDA is thought likely to publish its final guidance in early 2015.

Related article
Chinese guidelines for biosimilars

Reference
1.   GaBI Online - Generics and Biosimilars Initiative. China releases draft biosimilars guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 12]. Available from: www.gabionline.net/Guidelines/China-releases-draft-biosimilars-guidance

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