Development of biosimilars should grasp its characteristics
The world's leading multinational pharmaceutical company, France's Sanofi-Aventis, is committed to research and development of innovative treatment programs, especially in the field of biomedicine, and its research and development efforts in diabetes and anticoagulant drugs. Competition, etc., has become a leader in global biopharmaceuticals. As a leader in the field of biopharmaceuticals, it has a deep understanding of the characteristics of biopharmaceuticals, which is why it has unique analysis and insight into the market, development and management of biosimilars.
In this paper, the experts of Sanofi-Aventis explained to the reporter the development status of the biosimilar market, and pointed out that the characteristics of biopharmaceuticals determine that the market development of biosimilars in the future depends not only on government demand and the patent expired organisms. The quantity of products depends on the production technology level of biosimilars and the scientific supervision level of the government. At the same time, it is emphasized that it is impossible for different manufacturers to produce truly identical biological products using different production processes. Therefore, for biosimilars, the effectiveness and safety of the biosimilars need to be verified by more experiments. The ground is replaced with the test data of the original research product.
The introduction of experts in the US and European biosimilars management methods, as well as analysis and recommendations for biosimilars management, is worthy of reference and reference in the industry.
Market demand is obvious
Biosimilars differ from traditional generics in the development of the market relying on scientific supervision of
Since 2008, there has been a boom in biopharmaceutical development, investment, and attention in the global pharmaceutical market. Not only are patent biopharmaceutical companies expressing concern in this area, but many generic drug companies have also shown great interest. However, an expert from Sanofi-Aventis (China) (hereinafter referred to as Sanofi) pointed out in an interview that the development of biosimilars in a country or region depends to a large extent on whether Compliance with the characteristics of biosimilars and the level of government regulation.
“The rapid development of the biosimilars market is based on two foundations. First, new biopharmaceuticals are continuously approved; second, a large portion of existing biologics patents are about to expire, and by 2016, there will be approximately $25 billion in biologics. The patent protection will be lost.†Song Zengli, director of pharmaceutical affairs at Sanofi, told reporters that the global biopharmaceutical industry has experienced two leap-forward development stages: the first stage was the reorganization of insulin from 1982 to 1997, which was mainly a cell. Factor products, these products have entered a period of rapid development from the rapid growth period in the late stage of the first development stage of the bio-pharmaceutical industry (1994-1997), and as a result, the global bio-pharmaceutical industry has insufficient development momentum, and annual sales have been lingering. About $10 billion. After 1997, with the approval of a variety of therapeutic antibodies, the biopharmaceutical industry entered a second rapid development stage, and its growth rate remained above 15% for more than 10 years, making it one of the fastest growing high-tech industries.
The government's need to reduce health care pressure has also laid the foundation for the development of the biosimilars market. Most of the biopharmaceuticals are specialist drugs. Due to the limited market size of specialist drugs, in order to recover development expenditures, the pricing of specialist drugs is generally very high. Therefore, only by developing the biosimilars market can it significantly reduce the pressure on biomedical products for government health care.
Biosimilars are different from traditional generic
The huge capital and time investment in the research and development of new drugs has promoted the listing of “imitation medicine productsâ€. However, the guidelines issued by the European Medicines Agency (EMEA) Committee on Medicinal Products for Human Products on “similar biomedical products†clearly state that similar biomedical products are not considered to be generic medical products, and emphasize that in addition to the need for comparative studies to confirm their similarity In addition to safety and effectiveness, its products must also be fully characterized.
Song Zengli further explained that, unlike conventional generic drugs, because the production process of biopharmaceutical products is very complicated, there is actually no truly identical biological replica. Therefore, this generic product can only be studied in some properties. Similar to drugs, it is not as safe and equivalent as chemical imitations.
"The generic drugs we usually refer to are generally used to describe imitation products of small molecule chemical drugs. They are equivalent in structure and efficacy to original products with expired patents or data protection expired. But this evaluation method is not Applicable to the development, evaluation and approval of biosimilars.†Song Zengli pointed out that this is because biologics contain relatively large, complex and complex molecules, and the production process is very complicated, except for the planar primary structure. There are also complex secondary and tertiary space structures, and it is impossible for different manufacturers to produce truly identical biological products using different production processes. Therefore, for biosimilars (more precisely, the name should be biosimilars), the effectiveness and safety of the biosimilars need to be verified by more tests, and the test data of the original product cannot simply be used instead. For example, there are more than ten kinds of low molecular weight heparins used in clinical practice at home and abroad. Since some academic concepts in the field of anticoagulation have not been accurately distinguished, it is generally believed that low molecular weight heparin is the same. In fact, due to differences in production processes and chemical structures, the clinical efficacy and indications of different low molecular weight heparins are different. Therefore, the World Health Organization (WHO), the US Food and Drug Administration (FDA) and other institutions have been in the past few years. It was clearly pointed out before that the characteristics of a low molecular weight heparin could not be freely extended to another low molecular weight heparin. The clinical research results for a particular low molecular weight heparin could not be extended to other low molecular weight heparins. At the same time, the FDA has classified the management and classified low molecular weight heparin into different varieties according to the manufacturer and source.
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