China Releases Biosimilar Guidelines

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, took into effect immediately.

The document establishes basic principles for development and evaluation of biosimilars, including recommended studies and QC. Biosimilars should be submitted through the new drug approval pathway, although they will be reviewed based on a separate set of technical criteria. Biosimilars also needs to have the identical amino acid sequence as the reference drug. The reference drug shouldn’t itself be a biosimilar — and must be approved in China before beginning clinical trials for that biosimilar product.

It is anticipated that these guidelines will reduce biosimilar development costs for drug companies. However, approval time for a biosimilar product might not improve; it currently takes an average of 5 years for an innovative biologic to reach the Chinese market.

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