The Center for Drug Evaluation (the “CDE”) under the China Food and Drug Administration published final biosimilars guidance on February 28 with immediate effect. Officially titled the Technical Guideline for the Research, Development and Evaluation of Biosimilars (“Tentative”), the Guideline aims to address clinical needs for biologics in China by improving the accessibility and affordability of novel products. Biopharmaceutical companies will likely benefit from the Guideline, as it provides an alternative option for launching biologics in China.
Like the draft issued in November 2014 (please refer to our Alert on the draft dated November 5, 2014), the final Guideline sets forth basic principles for the technical review of biosimilars, the criteria for establishing biosimilarity, and the conditions under which extrapolations of indications are permissible. The Guideline clarifies some outstanding questions, such as the approval pathway for biosimilars relative to novel biologics, and adopts less stringent requirements, for example in the definition of a biosimilar and its reference product.
Key differences between the final Guideline and its previous draft are summarized in the following table.
| Final Guideline | November Draft | |
| Approval pathway | Like innovative biologics, biosimilars are subject to the new drug approval pathway, but their technical reviews will follow the principles and process defined in the Guideline. Companies must mark in their IND and NDA applications that the submissions are intended to be reviewed as biosimilars. | It was unclear if biosimilars would be subject to an abbreviated or a separate approval pathway from innovative biologics. |
| Definition of biosimilars | A biosimilar is defined as a therapeutic biologic that is similar to a reference product approved in China or elsewhere in quality, safety and efficacy; the biosimilar should in principle have the same amino acid sequence as the reference product’s. | A biosimilar was defined as a therapeutic biologic that is similar to an approved innovator biologic in quality, safety and efficacy, and that has the same amino acid sequence. |
| Definition of reference products | A reference product (including active ingredients used for production or extracted from finished products) to which a biosimilar product is compared in analytical and pre-clinical studies must be approved in China or elsewhere. The same reference product must be approved in China at the time when clinical studies are initiated. The reference product is usually, but not necessarily, the originator’s product. Nevertheless, approved biosimilars cannot themselves act as reference products. |
A reference product (including active ingredients used for production or extracted from finished products) to which a biosimilar product is compared in analytical and pre-clinical studies would have had to have been approved in China at all stages of clinical development. |
| Basis for consistency | In principle, samples used in all comparative tests should come from the same location of manufacture. | The principle statement was not included. |
| General considerations for comparative research | Companies are required to select representative batches of products as samples for comparative tests. Quality differences between each batch must be analyzed to identify the representative ones. | Companies should select at least 3 batches of products as samples for comparative tests. |
Currently, it can take at least 5-6 years for companies to launch innovative biologics in China. While biosimilars are subject to the same approval pathway as novel biologics with a set of different technical review criteria, it remains unclear if the time to market for biosimilars will be substantially reduced. Companies interested in developing biosimilars are advised to carefully review the Guideline and evaluate their product development strategies.
If you would like to discuss the foregoing or any other related matter, please contact Katherine Wang or your usual Ropes & Gray advisor.
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