As patent expiration of global monoclonal antibody biological drugs peaks, the biosimilars in China have entered the fast lane of development, and CFDA is now open to and encouraging biosimilar R&D, however, China still has a gap with the U.S. and EU in terms of biosimilar development. So far, the U.S. FDA has approved 9 biosimilars (7 monoclonal antibody products) in total, and there have been 40 varieties of biosimilars in 13 categories approved by EMA (14 monoclonal antibody products) in the EU. Please read the Talks on the Future Pattern of Biosimilars—U.S. and Talks on the Future Pattern of Biosimilars—EU for the details.
CFDA issued the Technical Guideline for Development and Evaluation of Biosimilars (Interim) in February 2015 to promote the sound development of the biomedicine industry, and with this, China’s biosimilar regulations began to be gradually improved; the Guideline gives clear guideline for the definition and R&D of biosimilars. The Measures for the Administration of Drug Registration (Revised Draft) issued in July 2016 further regulates the concept of biosimilar, and proposes that "the drug review shall focus on the similarities of biosimilars and original drugs in terms of quality and efficacy", etc. The Opinions on Deepening the Reform of the Review and Approval System and Inspiring Innovation of Drugs and Medical Devices jointly issued by the General Office of the Communist Party of China Central Committee and General Office of the State Council of China on October 8, 2017 again clearly proposes to "support biosimilars". However, there is still no biosimilar in the real sense applied for approval in China.
The technical threshold and investment threshold of biosimilars are much higher compared to the chemical generic drugs. From the perspective of technology, the same raw material, process and preparation method may lead to differences in protein product safety and effectiveness due to biological drug complexity, therefore, the critical process parameters and process control are very critical in the R&D process, many steps such as cell culture conditions (temperature and nutrition), product processing, purification, storage, and packaging, etc. will affect the production, and small differences in the whole process may have big impacts on the quality, purity, biological characteristics, and clinical effects of the final products. Furthermore, the quality standard setting and control are also a vital part. From the perspective of investment, it is thought that biosimilar R&D take 8-10 years or longer, while chemical generic drug R&D take 3-5 years; and in terms of the investment cost, a typical chemical generic drug generally costs USD 2-3 million, while a biosimilar costs up to USD 75-250 million, with the difference of about 100 times.
The global biosimilar R&D currently focus on the big monoclonal antibodies of which the patents have expired or will soon expire, such as adalimumab, infliximab, etanercept, rituximab, bevacizumab, and trastuzumab, and the case is the same for China, however, there are not many products applied for as biosimilars in China. Next, let’s focus on the R&D progress of several big monoclonal antibody varieties in China:
Rituximab
Rituximab originally developed by Roche is the world’s first monoclonal antibody approved for clinical treatment of Non-Hodgkin lymphoma (NHL), and was separately approved for marketing in the U.S. and EU in 1997 and June 1998.
The EU has approved 6 biosimilars of rituximab, separately being Truxima of Celltrion Healthcare Hungary Kft., Riximyo and Rixathon of Sandoz, and Blitzima, Rituzena (formally called Tuxella) and Ritemvia of Celltrion Healthcare Hungary Kft.
Rituximab entered China on April 21, 2008, with the trade name of Rituxan, being one of the three major monoclonal antibodies of Roche (rituximab/Rituxan, bevacizumab/Avastin, and trastuzumab/Herceptin). In China, the rituximab injection of Henlius under Fosun Pharmaceutical was included in the priority review on January 29, 2018, to enter th...
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