Edtor's Notes:
On November. 7th, Bio-Thera Solutions, Ltd., a clinical-stage pharmaceutical company, Onannounced that the China National Medical Products Administration (NMPA) has approved QLETLI® (格乐立®) for all eligible indications of the reference product, Humira® (adalimumab), in China.
Below are a previous article:
The marketing application of Bio-Thera’s adalimumab (acceptance No.: CXSS1800018) has recently been under the "under approval" status, which is expected to be approved for marketing soon for treating ankylosing spondylitis (AS). Bio-Thera has aroused discussions owing to its application for listing on the Sci-tech Innovation Board of China when it does not generate any revenue. If the company can successfully produce the first adalimumab biosimilar, this will be great news before its listing.
Annual sales of USD20.5 billion and 3 indications in China of the global drug king
TNF-ɑ (tumor necrosis factor-ɑ) is a known proinflammatory cytokine that mainly regulates immune cells. TNF-ɑ receptors can transduce survival and death signals to cells and play an important role in immune response regulation.
The original drug adalimumab (trade name: Humira) is a fully human anti-TNF-ɑ antibody of AbbVie, which was approved for marketing in the U.S. in 2002. It has been successively approved for 10 indications for more than a decade, including rheumatoid arthritis (RA), AS, plaque psoriasis, Crohn's disease (CD), juvenile idiopathic arthritis, and uveitis, etc. Its annual sales have been ranking first in the world for 7 consecutive years, with the global sales revenue of USD20.5 billion in 2018. And its therapeutic effects in autoimmune diseases have been extensively demonstrated.
The original drug adalimumab was approved for marketing in China in 2010 and is now approved 3 indications, i.e., RA, AS, and plaque psoriasis; and its CD indication has been completed the Phase III clinical trial. The original drug adalimumab was included in the List of the Second Batch of Overseas New Drugs Catering to Clinical Urgent Needs by the CDE in May 2019 for treating uveitis. This indication may be submitted data according to the Work Procedures for the Review and Approval of Overseas New Drugs Catering to Clinical Urgent Needs and directly filed the marketing application and will enjoy the priority review and approval.
The median bid-winning price of this original drug was RMB7,586/piece (40mg/0.8ml) in China in 2018. The cost of a patient using the drug according to the package insert will be nearly RMB200,000 a year. Such a high cost has restricted the accessibility of the drug to the broad patients. This original drug has not entered China’s national medical insurance drug catalog and only entered the medical insurance drug catalogs for major and serious diseases in some places, such as Chengdu City Medical Insurance Drug Catalog for Major and Serious Diseases, Shenzhen City Supplementary Medical Insurance Drug Catalog for Major and Serious Diseases, and Qingdao City Catalog of Special Drugs, Special Medical Consumables and Precision Diagnosis and Treatment Items of Supplementary Medical Insurance.
Size of the adalimumab biosimilar market may reach RMB11.5 billion in China in 2030
According to a report by Frost & Sullivan, China’s adalimumab biosimilar market is expected to increase to RMB4.7 billion in 2023 and reach RMB11.5 billion in 2030.
Size of China’s Adalimumab Biosimilar Market in 2020-2030
中国阿达木单抗生物类似药市场规模（亿人民币） 增速 | Size of China’s adalimumab biosimilar market (RMB one hundred million) Growth |
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