Anyone seen China’s draft biosimilars guidelines? Apparently there are some

By Gareth Macdonald contact

- Last updated on GMT

...or draft guidance documents on biosimilars?
...or draft guidance documents on biosimilars?

Related tags: China, Pharmacology

Biosimilar developers targeting China have just three weeks to first find and then comment on draft guidelines released by the CFDA.

Reports and tweets this week suggest the Chinese Food and Drug Administration (CFDA) opened up its “Draft Technical Guideline for the Research, Development and Evaluation of Biosimilars” for public comment earlier this month and set a deadline of November 29 for feedback.

However, none of the reports link to any documents and, at the time of going to press, no draft biosimilars guidelines were listed on either the Mandarin​ or the English​ language versions of the CFDA website.

According to law firm Ropes and Gray​ the document includes a requirement that reference products used by biosimilar firms need to be approved in China, which is likely to raise a few eyebrows given comments by the European Medicines Agency (EMA) in its new guidelines​.

Bridging studies

Last month, the EMA released revised biosimilar guidelines which, while maintaining the requirement that reference biologics must be approved in the EEA, introduced the concept of 'bridging studies' whereby data from a drug that is representative of such a product can be used.  

The London-headquartered agency said the revision “is designed to help developers avoid repeating costly early phase research and clinical trials​” adding that “it will be the Applicant's responsibility to demonstrate that the comparator authorised outside the EEA [European Economic Area] is representative of the reference product authorised in the EEA.​”

This will involve proving the non-EEA drug is of comparable quality which means “side-by-side analysis of the biosimilar product, from commercial scale and site, with EEA authorised reference product must be conducted” ​according to the Agency.

Without seeing a copy of the Chinese biosimilar draft guidelines it is impossible to tell if any such provisions are included.

As soon as Biopharma-Reporter.com finds a copy of the draft guidelines we will let you know about it.

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