A drug has been approved for marketing on an ordinary day! It seems nothing, but in fact, it means something! This drug is Hanlikang, and its presence has formally started the era of biosimilars in China! (Read More: Biosimilars that have entered Phase III clinical trials)

Rituximab Injection (trade name: Hanlikang) developed by Henlius has been approved by NMPA for marketing on Feb. 22, 2019. It is the first biosimilar approved in China, and is an anti-CD20 monoclonal antibody mainly used to treat non-Hodgkin lymphoma.
The world of biosimilars in China is in hot battle. Which will be the next "Hanlikang"?
The next 5 years will be the rapid development period of biosimilars
Biosimilars enjoy big growth in 2013-2022 as many blockbuster biological drugs become off-patent. According to the forecast of IMS, the share of global biosimilars will reach 20% of the overall biological drug market in 2019, and the market size of biosimilars in the Europe and U.S. alone will reach up to USD110 billion by 2020. The next 5 years will be the rapid development period of biosimilars.
Expiry Time of Patents of Some Top Biological Drugs
Pharmaceutical product | Company | Marketing approval time (Europe/U.S.) | Patent expiration date (Europe/U.S.) |
Humira (adalimumab) | AbbVie | 2003/2002 | 2018/2016 |
Enbrel (etanercept) | Pfizer/Amgen | 2000/1998 | 2015/2028 |
Herceptin (trastuzumab) | Roche | 2000/1998 | 2014/2019 |
Avastin (bevacizumab) | Roche | 2005/2004 | 2022/2019 |
Rituxan (rituximab) | Roche | 1998/1997 | 2013/2016 |
Remicade (infliximab, top13) | J&J/MSD | 1999/1998 | 2015/2018 |
Neulasta (top17) | Amgen | 2002/2002 | 2017/2015 |
(Organized according to public data)
"Three carriages" boost the biosimilars in China to usher in the "golden age"
Firstly, technological progress has provided the essential condition for the successful development of biosimilars; secondly, the continued improvement of policies of and regulation over biosimilars has promoted the sound development of the biosimilar industry; finally, the increasing coverage of biosimilars by the medical insurance has enabled the biosimilar development scale to expand.
Technological level | Big progress in fields of phage display technique, fully humanized antibody technique, and hybridoma technology, etc.; Breakthroughs in mass production, a difficulty for biological drugs, and in key techniques such as large-scale culture of engineering cells, construction of high expression vectors,... Read More
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