Generic Atorvastatin Selected in China's National Centralized Drug Procurement Demonstrates Equivalent Efficacy and Safety to Originator in Real-World Multicenter Study

Recently, the Expert Symposium on the Progress of Lipid Management Strategies and Therapeutic Drugs Research, hosted by Xuanwu Hospital of Capital Medical University, was successfully held in Jinan. Pharmaceutical experts from medical institutions across China gathered to discuss new topics in lipid health management.

Zhang Lan, Director of the Pharmacy Department of Xuanwu Hospital, Capital Medical University, gave a presentation titled "Evaluation of the Efficacy and Safety of Atorvastatin Generic Drugs Based on Real-World Data," sharing the research methods, processes, and interim results of the comprehensive clinical evaluation study of atorvastatin generic drugs. According to current research findings, in terms of major efficacy indicators, safety, and compliance, the atorvastatin generic drug (Meidaxin)...^®) No difference was observed compared to the original drug.

Centralized Volume-based Drug Procurement: A Key Initiative in Advancing Supply-side Reform in Medical ServicesCentralized volume-based drug procurement in China plays a crucial role in enhancing public welfare, driving the linkage reform of medical insurance, medical services, and pharmaceuticals, and promoting the healthy development of the pharmaceutical industry. The national centralized volume-based drug procurement mandates that selected generic drugs must pass the consistency evaluation. Actively conducting real-world studies on the clinical efficacy and safety of selected generics can provide scientific evidence-based medical data to support the formulation and implementation of procurement policies across China.

Real-World Study on the Efficacy and Safety Evaluation of Atorvastatin Generic Drugs Launched in September 2023

Pharmaceutical experts engaged in a heated discussion on how to enhance the confidence of medical institution staff and patients in the quality of selected generic drugs under the常态化 centralized procurement system. They fully expressed their confidence in the high-quality and cost-effective selected generics. The conference also invited Professor Jianjun Li from Fuwai Hospital, Chinese Academy of Medical Sciences, to interpret the evaluation indicators of the "China Lipid Management Guidelines (2023)," reaffirming the cornerstone地位 of atorvastatin in lipid-lowering treatment.

Atorvastatin is one of the most widely used lipid-lowering drugs globally. Atorvastatin Calcium Tablets (Meidaxin) developed and produced by Qilu Pharmaceutical.^®) Passed the consistency evaluation and was selected for the national drug centralized procurement in December 2019. With the successful renewal, it not only achieved large-scale import substitution of domestically produced drugs, significantly reducing the economic burden of medication for patients, but also saved billions of yuan in medical insurance funds for the country each year.