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, and high-throughput cell culture and screening, and increase of reactor scale by order of magnitude |
Policies and regulation | In 2007, CFDA (now NMPA) officially issued the Provisions for Drug Registration to stipulate that biological products should be applied for according to the new drug application procedure; In 2015, CDE issued the Technical Guideline for Development and Evaluation of Biosimilars (Interim) to regulate relevant registration requirements such as biosimilar application procedure, registration category, and application data; In 2016, the Provisions for Drug Registration (Revised) specially mentions "with respect to a biosimilar drug, its consistency with the original drug in terms of quality and therapeutic effect"; In 2017, the Principle and Procedure for Nonproprietary Naming of Biological Products (Draft for Comment) was issued, to further pave the way for Chinese biosimilars to go international |
Medical insurance coverage | 7 monoclonal antibodies have successively entered the Category B list of medical insurance of some provinces in China since 2009; In Feb. 2017, the Human Resources and Social Security of China released the new edition of medical insurance drug catalog, to include 2 monoclonal antibody drugs into the Category B list of China’s national medical insurance for the first time; On Apr. 14, 2017, the Human Resources and Social Security of China started the negotiations about medical insurance drug catalog, and 6 monoclonal antibody drugs were successfully included into the said catalog upon negotiations; On Mar. 28, 2019, Guangxi Public Resource Transaction Center Drug and Medical Device Centralized Procurement Office released the "Notice on Including Generic Drug Varieties of Negotiated Pharmaceutical Products for Centralized Procurement among the 36 Pharmaceutical Products in National Negotiations (Fourth Batch)", wherein, Hanlikang is included |
(Organized according to public data)
Five targets are the hottest in the R&D
The biosimilars in development in China mainly cover the five targets CD20, EFGR, VEGF, TNF, and HER2, wherein, Henlius is at the top 1 position, with layout for all the 5 targets, followed by Bio-Thera, Innovent, and Hisun, with layout for 3 targets. The anti-TNF monoclonal antibody biosimilars of Sunshine Guojian, Qilu, and Hisun have been at the production application stage, and Bio-Thera’s adalimumab biosimilar BAT1406 has been filed the marketing application in Aug. 2018.
Read More:
Biosimilars that have entered Phase III clinical trials
(Organized according to public data, by Apr. 3, 2019)
Reference: [Special Report on Biosimilars] In-depth Analysis of the Process of Biosimilar’s Substitution of Original Drugs in Europe and China
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