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.
|
Ranking |
Drug |
Indication |
Company |
2015 USD 100 million |
Sales proportion |
2016 USD 100 million |
Sales proportion |
|
1 |
Humira |
Autoimmune disease |
AbbVie |
140.1 |
61.3% |
160.8 |
63% |
|
2 |
Harvoni (sofosbuvir + ledipasvir) |
Anti-infection |
Gilead |
138.6 |
42.5% |
90.8 |
29.9% |
|
3 |
Enbrel (etanercept) |
Autoimmune disease |
Amgen/Pfizer |
53.6 (Amgen), 33.3 (Pfizer) |
28% (Amgen), 7% (Pfizer) |
59.6 (Amgen), 29.1 (Pfizer) |
26% (Amgen), 6% (Pfizer) |
|
... Read More
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