On the difference between original drugs and generic drugs

Original drug: This is a unique concept in China. It does not refer to all patented drugs, but also includes some generic drugs. According to the regulations of the National Development and Reform Commission, patented drugs with expired compound patents (including the end of the administrative protection period) and similar drugs (drugs that failed to apply for patent protection in China, but were listed for the first time in China, and potentially covered generic drugs) * * * together constitute the original research drugs in the China market, and the original research drugs are mainly concentrated in wholly foreign-owned and Sino-foreign joint venture pharmaceutical companies. The original drug was put forward only after the unified government pricing was implemented in 2000. The main purpose of establishing the original research drug is to encourage the research and development of new drugs, strengthen the protection of intellectual property rights, and maintain the reasonable price of drugs. At the same time, it is also to reflect the basic principle that the difference between drug quality and efficacy is the difference in pricing. This is not the same concept as the new class of chemicals stipulated in China's Measures for the Administration of Drug Registration. The new class of chemicals covers a wider range and has different concerns. In practice, even after the patent expires, the original drug still enjoys the "super-national" treatment in China, which not only enjoys the pricing power, but also is not subject to price restrictions even in the case of generic drugs, so it is protected in disguise and is in an absolute advantage in the market competition with generic drugs.

Generic drugs: generic drugs refer to imitations that are the same as generic drugs in terms of dosage, safety and efficacy, quality, function and indications. The relevant documents of FDA in the United States point out that generic drugs that can be approved by FDA must meet the following conditions: they contain the same active ingredients as imitation products, and the inactive ingredients can be different; Consistent with the indications, dosage forms, specifications and routes of administration of the copied products; Bioequivalence; Quality meets the same requirements; GMP standards produced are as strict as imitation products. Its main feature is to use some recognized and mature theories and technologies, as well as existing equipment and materials, to develop "cheap and good quality" existing products. Therefore, what is displayed here is more integrated innovation. In the process of research and development of new generic drugs, there are also independent innovation activities, because even if the molecular entity of this new drug is no longer protected by patents, the preparation process, crystal form and composition will still be protected by patents; Even if the preparation process is not protected by patent, there will still be many technical barriers of "proprietary technology". Therefore, in this kind of innovation activities, it is mainly through the innovation of preparation technology, including inventing new technologies that can bypass the existing process patents, breaking through some key technologies that restrict industrialization, and integrating existing technologies, equipment and materials, and finally obtaining a process route with certain independent intellectual property rights, low preparation cost, excellent product quality and environmental protection.