Current Situation of Biosimilars in China I: A Focus on the Biosimilar Market in China

According to the financial reports issued by global pharmaceutical giants in 2016, 7 biological drugs entered the list of global top 10 best-selling drugs. The generic drugs of blockbuster biological drugs continue to increase as the latter’s patents expire. "Biosimilar" is no longer a new word, and many insiders can talk something about it. There have been many biosimilars marketed in the EU and U.S. where the biosimilar approval and regulation policies are relatively perfect. The biosimilars in China stated late, and relevant policies in this aspect have been fast developing in recent years. I have noticed recently that Chinese enterprises such as Luye Pharma, Simcere Pharmaceutical, and Henlius have made milestone progress in biosimilars. As relevant articles I read did not give all-round summaries, I’d like to make a summary of biosimilars in China from several aspects, which will cover the overview of Chinese biosimilar market and distribution of biosimilar targets, summary of core patents of key biosimilars, development situation of key biosimilars in China, and biosimilar policies in China, etc., and take two articles. This article focuses on the overview of Chinese biosimilar market, and distribution of biosimilar targets.

I summarized the annual financial reports issued by pharmaceutical giants and conducted product analysis at the beginning of 2017. See the following table for the detailed data: 7 were biological drug among the top 10 drugs by sales; the total sales of the top 10 drugs were USD 82.682 billion, and sales of biological drugs accounted for 73.67%; the total sales of top 200 drugs were about USD 357.2 billion, and sales of biological drugs accounted for 44%; monoclonal antibody drugs were a category that could not be ignored, wherein, monoclonal antibodies/fusion proteins represented by Humira, Enbrel, Remicade, Mabthera, Herceptin, and Avastin became the absolute mainstay, contributing 63% shares of the monoclonal antibody market.

There is no doubt that biosimilars will fast follow up as blockbuster drugs become off-patent. From the perspective of global biosimilar market, authoritative bodies had different judgments regarding the biosimilar market from several aspects: 1. Frost & Sullivan forecast that the global biosimilars will grow at 53.7% compound annual growth rate (CAGR) from 2016 to 2021, and reach sales of USD 36.6 billion in 2021; 2. Macquarie Research also mentioned that the biosimilars would fast grow from 2016 to 2020, with CAGR of nearly 40%.

Then, what are the prospects of the Chinese biosimilar market? The Chinese biosimilar market has just started, and biosimilars have small market shares. Due to the development lag of biosimilar approval policies, there are more manufacturers developing and marketing biosimilars such as EPO, growth hormone, and colony-stimulating factor, with total sales of only RMB 4 billion. If to forecast the prospects of the Chinese biosimilar market of blockbuster monoclonal antibody drugs in the future, the Chinese biosimilar market may be around RMB 20-30 billion in 2020 in my opinion, which is reckoned based on the 10% market shares of Chinese biological drugs among global biological drugs. Quality of biosimilars is improving as policies become perfect. We will wait and see which enterprise will stand out on the biosimilar market.

II. Focus: biosimilars of six blockbuster monoclonal antibodies

According to open data, there are 269 biosimilars in development in China, ranking high in the world. And it is evident from biosimilar policies and reviews in China that as biological drugs not of monoclonal antibody category, such as growth hormone, erythropoietin, interferon, and insulin glargine, were off-patent in 2013-2015, relevant products started to be marketed intensively, and same products thereof were marketed by many manufacturers, showing obvious vicious competition.

As blockbuster monoclonal antibody drugs become off-patent in 2015-2020, development of biosimilars in China will focus on the biosimilars of six blockbuster monoclonal antibodies/fusion proteins, namely, Humira, Herceptin, Remicade, Enbrel, Avastin, and Mabthera, wherein, there have been 3 biosimilars of Enbrel marketed, separately, Yisaipu of CP Guojian Pharm, Qiangke of Shanghai Celgen, and Anbainuo of Zhejiang Hisun. Therefore, the main targets of biosimilars are CD20, HER2, TNFa, and VEGF, which are the hotspots of research of biosimilars or me-better drugs, and certainly, targets of other monoclonal antibody drugs such as PD-1, CTLA4, RANK, and TIM3 are also the focuses of innovative drug/biosimilar development of Chinese enterprises.

Furthermore, some Chinese enterprises involving biosimilar development are quite noteworthy, such as Alphamab, Qilu Pharmaceutical, Genor Biopharma, and CP Guojian Pharm, wherein, Sunshine Guojian Pharmaceutical (CP Guojian Pharm) already has products marketed or applied for production, and will undoubtedly be at an advantage in the future biosimilar competition in China. And I always believe that biosimilars can enable an enterprise to grow, however, those that will make them truly strong are me-better or innovative drugs. Biosimilars will certainly be confronted with many problems in future competition, for example: 1. The pricing and promotion strategies. In fact, biosimilars will not undergo large price reduction like chemical generics, therefore, how to promote and price them in China where the income level is relatively low becomes very important; 2. How to strongly compete with original drugs, to strive to enter the medical insurance catalog, is quite an important factor; 3. Biosimilars will certainly show performance differences with original drugs in treating long-term, chronic, acute or critical diseases. It is my hope that Chinese biosimilars could experience fast and quality development, to truly bring "good drugs" to patients.

Keep Reading: Current Situation of Biosimilars in China II: 2016-2020 will be the Prime Time of Biosimilars