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With the "explosion of semaglutide", the "miracle drug for weight loss", how to standardize supervision has become an urgent problem to be solved. Recently, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) publicly released the "Guidelines for the Design of Clinical Trials for the Indications of Biosimilar Weight Management of Semaglutide Injection (Draft for Comments)". The guiding principle is clear that the biosimilar of semaglutide injection should be based on the original drug of Novo Nordisk marketed in mainland China as the reference drug, and pharmacokinetic comparison tests and clinical safety and efficacy comparison trials should be carried out to support the registration and marketing of biosimilars.
In this context, the marketing application of semaglutide injection "Jiyoutai" submitted by Hangzhou Jiuyuan Genetic Engineering Co., Ltd. (hereinafter referred to as "Jiuyuan Gene") was accepted, and it became the first semaglutide biosimilar to be declared for marketing in China, with the indication for blood sugar control in adult patients with type 2 diabetes, which also marked the beginning of the domestic semaglutide commercialization competition.
Internationally, GLP-1 drugs represented by Novo Nordisk's semaglutide have long been approved for marketing, and Novo Nordisk has already made a lot of money. In China, semaglutide has not yet been approved for weight loss indications. At present, domestic pharmaceutical companies semaglutide have entered the phase III clinical stage, including Jiuyuan Gene, Huadong Medicine, Jiuyuan Gene, Bowei Biotechnology and other companies, and it will still take time to use domestic semaglutide for weight loss.
With the increasingly fierce competition in the market, some analysts in the pharmaceutical industry said that at the level of GLP-1 R&D layout, time barriers, differentiated drug design, and excellent drug efficacy are the keys to success. If the same product has faster clinical progress and earlier commercialization, it will have a greater first-mover advantage in the hospital market. At the same time, it can also be seen from past sales data that the market share of long-acting GLP-1 formulations is rising.
Looking back at the development of the mainland biosimilar industry from the "first domestic biosimilar application for marketing":
——The essence of biosimilars is "generic drugs", and the structure of biosimilars is complex and difficult to imitate
According to the definition in the Technical Guidelines for the R&D and Evaluation of Biosimilars (Trial) issued by the National Medical Products Administration, biosimilars are therapeutic biological products that are similar to the reference drugs that have been approved for registration in terms of quality, safety and efficacy. A biosimilar is an imitation of the original drug, and the biosimilar can only be approved after the patent protection of the original drug expires. Many countries are placing great emphasis on the development and management of biosimilars because they can better meet the public demand for biotherapeutics and help improve access and reduce the price of biologics.
- More than 30 biosimilars have been approved for marketing
As of September 8, 2023, more than 30 biosimilars have been approved for marketing in China. From the perspective of approved biosimilar reference drugs, bevacizumab is the most popular reference drug, and 10 biosimilars have been approved for marketing in China; This is followed by adalimumab, which has been approved for marketing by seven biosimilars.
-- The market size of China's biosimilar industry
The high price is the main reason for the low penetration rate of the original drug in China, and the R&D cost of biosimilar drugs is lower than that of the original drug, so it has a price advantage. According to the Frost & Sullivan report, the market size of China's biosimilar industry was about 1.6 billion yuan in 2018 and about 18.9 billion yuan in 2022, with an average annual compound growth rate of about 85.39% from 2018 to 2022.
According to the analysis of the Prospective Industry Research Institute, the government's policy support and capital investment, as well as the continuous improvement of scientific research strength, provide a solid foundation for the research and development of biosimilars. Huge market potential, enhanced international competitiveness and technological breakthroughs will promote the emergence of biosimilars in China and the global market. By 2028, the market size of China's biosimilar industry may reach 52.2 billion yuan, with broad market prospects, with an average annual compound growth rate of about 15.05% from 2023 to 2028.
Prospective Economist APP Information Group
For more research and analysis of this industry, please refer to the "Analysis Report on the Development Prospect Forecast and Investment Strategic Planning of China's Biopharmaceutical Industry" by Qianzhan Industry Research Institute.
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