The marketing application status of Hisun Pharmaceutical’s Adalimumab Injection changed to "Approval completed-to be issued certificate" on Dec. 9, which means that the 2nd Chinese-produced adalimumab biosimilar is on the way following the approval of the first Chinese-produced adalimumab injection, i.e., Bio-Thera’s QLETLI, on Nov. 6, and the drug king Humira will have a new rival in the Chinese market.
Marketing Application of Hisun Pharmaceutical’s Adalimumab Injection | ||||
Pharmaceutical product name | Acceptance No. | Registration class | Handling status | Status start time |
Adalimumab Injection | CXSS1800025 | Therapeutic biological products 2 | Approval completed-to be issued certificate | Dec. 9, 2019 |
Source: CDE
The original drug adalimumab belongs to AbbVie, with the trade name Humira. Humira has topped the global best-selling drug list for 7 consecutive years since it was marketed in 2002.
Humira entered China in 2010. Despite the astonishing overall sales in the world, Humira does not have high market penetration in China largely because of the expensive price: the median bid-winning price of 40mg/0.8ml Humira in China is RMB7,586/piece, and some bid-winning prices reach RMB7,820/piece. The expensive treatment cost has restricted its accessibility to the patients in China.
The adalimumab injection developed by Bio-Thera was approved by the NMPA for marketing on Nov. 7, with the trade name QLETLI, and becomes the first Chinese-produced adalimumab biosimilar approved in China. Therefore, Humira will be faced with competition from Chinese local biosimilars. And the sales revenue of Humira in the first half of 2019 reached USD9.316 billion, down by 5.8% year on year, showing a declining tendency.
Humira in China was listed according to the medical insurance payment standard of RMB1,290 in the negotiated national reimbursement drug list (NRDL) of China in 2019 issued by the National Healthcare Security Administration and Ministry of Human Resources and Social Security of the People's Republic of China at the end of November, with the price down by 83.5%. Humira’s entry to the NRDL through a large price decline aims to seize the market share, drive the rapid growth of the product in the Chinese market and improve its competitive edge over Chinese-produced biosimilars.
AbbVie’s Humira has been approved 4 indications in China, separately rheumatoid arthritis (RA), ankylosing spondylitis (AS), plaque psoriasis, and polyarticular juvenile idiopathic arthritis (pJIA). Its indications approved in China are fewer than those approved in other countries. AbbVie is expected to accelerate the registration application for new indications in China in the future.
Flocking to developing adalimumab biosimilar in the Chinese market
According to statistics, the number of patients of AS, RA, and plaque psoriasis is separately about 5.90 million, 5.88 million, and 2.85 million in China. Those patients lacked safe and effective drugs before adalimumab was marketed, and there are huge market demands behind.
The core patent of adalimumab has expired in China in 2016, and many Chinese pharmaceutical enterprises have laid out adalimumab biosimilar early. Besides Bio-Thera’s QLETLI approved for marketing and Hisun Pharmaceutical’s product to be approved, adalimumab biosimilars of Innovent and Henlius have been successively filed the marketing application to the NMPA, and similar products of nearly 20 enterprises have also entered the clinical stages. Indications developed for the Chinese-produced products are centrally RA, AS, and plaque ...
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