Presently, no abbreviated pathway is available in China for biosimilars.  Accordingly, any biopharmaceutical drug (biologic or biosimilar) must be filed as a new drug application.  A new drug application takes anywhere from five to ten years and costs from one to ten million U.S. dollars.  However, industry insiders are reporting that guidelines establishing a biosimilar pathway in China are expected to be released by the end of June with regulations to follow by the end of the year.  Specifically, the Center of Drug Evaluation (CDE), which is the registration arm of the Chinese Food and Drug Administration (CFDA), expects the guidelines to “fill in” regulatory blanks as well as raise industry standards for biosimilars.  Reports from China are that the CDE has put significant effort into drafting the guidelines.

Although the guidelines have not yet been released, the issue of naming of biosimilars is already the subject of a great deal of discussion in China.  Several Chinese biopharmaceutical companies are pushing the CDE to adopt the European Medicines Agency’s regulations on naming, namely, that biosimilars share the same international nonproprietary name (INN) as the reference drug and have a unique name for the active substance to be used in conjunction with the company name.  With respect to clinical trials, many Chinese biopharmaceutical companies appear to be in agreement that biosimilar clinical trials should focus on the “similarity” of the biosimilar with the reference drug.

The status of several biosimilar drugs in China is provided below:

Non-antibody based biosimilars:

Interferon – several products approved.

Insulin – several products approved.

Erythropoietin – several products approved.

Interleukin 2 (IL2) – several products approved.

G-CSF – several products approved.

Biosimilar Antibodies:

Etanercept (Enbrel®) – at least eight companies have applications pending; at least three products from domestic companies are approved.

Infliximab (Remicade®) – at least two companies have applications pending.

Adalimumab (Humira®) – at least nine companies have applications pending; at least one product is approved.

Bevacizumab (Avastin®) – at least six companies have applications pending; at least two products are approved.

Trastuzumab (Herceptin®) – at least seven companies have applications pending; at least one product is approved.

Rituximab (Rituxan®) – at least eight companies have applications pending.

Cetuximab (Erbitux®) – at least three companies have applications pending.

Nimotuzumab – at least one company has an application pending.