China releases draft biosimilars guidance

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On 29 October 2014 China’s Center for Drug Evaluation (CDE) published draft guidance for approval of biosimilars.

China FDA V14K13

CDE, which is part of the China Food and Drug Administration (CFDA) (simplified Chinese: 国家食品药品监督管理总局) – the Chinese authority that oversees all drug manufacturing, trade, and registration in the country – has released the draft guidance for a one-month consultation period.

The new draft guidance establishes the principles of comparability, a step-wise approach to testing, consistency of the samples used and of similarity. A step-by-step procedure in which ‘no or little difference’ in comparability testing found could allow subsequent comparability tests to be skipped.  The guidance is applicable to well-characterized therapeutic recombinant proteins with clear functions.

The draft guidance defines ‘biosimilars’ as therapeutic biological products that are similar to the reference drugs in terms of quality, safety and efficacy, and that have the same amino acid sequence. The reference drugs have to be an originator biological approved in China.

The draft guidance also allows for extrapolation of indications, which will be considered on a case-by-case basis.

Draft guidance for research and evaluation techniques for biosimilars
Released for consultation: 29 October 2014
End of consultation: 29 November 2014 

Until the finalization of this guidance, biosimilars in China will still have to go through a new drug approval process, as is the case for all biologicals. This means that phase III trials have to be carried out [1].

The biosimilars guidance is expected to further improve regulations on technical requirements and the quality control of biologicals to streamline the approval process and speed up drug registration, which can take five to six years.

Feedback on the draft guidance can be submitted to the CDE until 29 November 2014. The CDE does not state when it expects a finalized guidance to be ready.

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1.   GaBI Online - Generics and Biosimilars Initiative. China to release biosimilars guidelines []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 14]. Available from: 

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Source: CDE

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