The China Food and Drug Administration (CFDA) released the country’s first biosimilar guidelines on February 28, 2015. The final guidance, based on a draft released in November 2014, went into effect immediately.
The document establishes basic principles for development and evaluation of biosimilars, including recommended studies and quality control. Biosimilars should be submitted via the new drug approval pathway, although they will be reviewed according to a separate set of technical criteria. Biosimilars should also have the same amino acid sequence as the reference drug. The reference drug should not itself be a biosimilar — and must be approved in China before starting clinical trials for the biosimilar product.
It is expected that these guidelines will reduce biosimilar development costs for drug companies. However, approval time for a biosimilar product may not improve; it currently takes an average of 5 years for an innovative biologic to reach the Chinese market.