On June 16, the marketing application for Adalimumab Injection submitted by Chia Tai Tianqing was accepted by the Center for Drug Evaluation (CDE). This makes Chia Tai Tianqing the sixth manufacturer in China to submit a biosimilar application for Humira, following Bio-Thera Solutions, Hisun Pharmaceutical, Innovent Biologics, Henlius Biotech, and Junshi Biosciences. Among these, Bio-Thera Solutions and Hisun Pharmaceutical received approval in November and December 2019, respectively.
On November 28, 2019, the results of the national medical insurance negotiations were announced, with AbbVie’s Humira included at a reimbursement standard of RMB 1,290 per pre-filled syringe. Following the successful negotiation for Humira, the adalimumab injections from Hisun Pharmaceutical and Bio-Thera Solutions were directly included in the national medical insurance coverage.
On January 2, the Shaanxi Provincial Drug and Medical Device Centralized Procurement Network released the “Public Notice on the Direct Online Listing of Adalimumab Injection.” The notice stated that adalimumab injections produced by Hisun Pharmaceutical and Bio-Thera Solutions could be directly listed for online procurement in Shaanxi Province. Hisun’s Anjianning (adalimumab) (0.8 mL: 40 mg) was priced at RMB 1,150 per pre-filled syringe, which is RMB 140 lower than Humira.
Bio-Thera’s Geleli (adalimumab) pricing was subsequently announced at RMB 1,160 per pre-filled syringe. According to Bio-Thera’s Q1 2020 quarterly report, Geleli generated sales revenue of RMB 19 million in the first quarter of 2020. Data from the PharmaGo Bid Winning Database by Yiyao Mofang indicates that Geleli’s price was reduced for the first time to RMB 1,150 in Zhejiang Province in March this year, and further lowered to RMB 1,150 in Hunan Province in May.
On April 1 this year, the CDE also released the "Guidelines for Clinical Trials of Biosimilar Adalimumab Injection (Draft for Comments)," which outlined the general requirements for the development of biosimilar adalimumab injection from four aspects: overview, clinical research strategy, key points of clinical study design, and summary.