I have forecast the biosimilar market and future development space in China in last article: the Chinese biosimilar market can reach RMB 20-30 billion in 2020, the volume of growth hormone, erythropoietin, and interferon, etc. will grow slowly, accompanied with serious vicious competition, and the current biosimilar development focuses on six blockbuster monoclonal antibody drugs. The next five years will be a very critical period for biosimilars with the improvement of CFDA’s biosimilar approval policies and patent expiration of blockbuster biological drugs. In this article, I’d like to further interpret the development of biosimilars in China from the perspectives of patents of monoclonal antibody drugs (only patents of the 6 blockbuster monoclonal antibodies mentioned in last article) and biosimilar approval policies in China.

I. Off-patent time of blockbuster monoclonal antibody drugs

We know that the patent barriers are a key aspect restricting the biosimilar development. Patents shall certainly be paid close attention to for the development of biosimilars. I have searched the patent applications of 6 blockbuster monoclonal antibody drugs through Patent Search and Analysis of SIPO (http://www.pss-system.gov.cn/) and compared and analyzed the patent expiry dates of the global 6 blockbuster monoclonal antibody drugs, as shown in the attached table. The patents here mainly refer to the core patents applied for certain monoclonal antibody drug in the EU, U.S., and China, etc., and surrounding patents thereof are omitted here. We can see that the patents of 6 blockbuster monoclonal antibody drugs in China will expire during 2015-2020, wherein, there has already been the biosimilar of the TNFa-targeted Enbrel fusion protein drug in China, which has been marketed in China before patent expiration of Enbrel.

II. Approval of biosimilars to be gradually improved in China

Biosimilar regulation policies also started late in China. I have searched the CFDA, and then summarized relevant review and approval policies on biosimilars in China in recent years, and briefly commented on their respective important impacts on the biosimilar review and approval. The CFDA also has introduced the "priority review" policy in recent years, specifying that the approval of innovative drugs or generic drugs that have significant clinical advantages, and are clinically imperative but short in market supply, etc. shall be implemented the priority review, which will undoubtedly significantly boost the development of biosimilars.

Biosimilars represent an opportunity for Chinese enterprises, but how to develop biosimilars is also a challenge. Biosimilars and original drugs are wrestling in many aspects. The Chinese biosimilar market will undergo much development in the next 5 years. In next article, I will introduce the current situation of biosimilar R&D enterprises in China, and from the perspective of the 5 blockbuster monoclonal antibody drugs (omit Enbrel as its biosimilar has been marketed), summarize the current development situation of biosimilars of those products in China: which biosimilar will be the first to be applied for production, which enterprise is the fastest in progress, and what are the characteristics of the main biosimilar development enterprises. Please stay tuned!

Keep Reading: Current Situation of Biosimilars in China III: Analysis of Biosimilars of Five Blockbust