The opportunity and challenge of generics from the perspective of gratimex acetate

About the author: Hou Yingwei, Ph.D in pharmaceutical chemistry, Institute of medicine, Chinese Academy of Medical Sciences, started to carry out research in the Institute of medicine, Chinese Academy of Medical Sciences in 2009 and participated in the research of Bill Gates fund and other projects Since September 2013, he has been engaged in postdoctoral research in school of medicine, Ocean University of China He has published articles in Journal of organizational chemistry, chemistry and biology and other academic journals On April 16 this year, Novartis announced that the generic generics of gratemer acetate developed by Sandoz, a subsidiary of Novartis, had been approved by the FDA of the United States and had been marketed under the brand name of glatopa The original manufacturer of grateme acetate is Teva pharmaceutical in Israel In 1996, grateme acetate was listed as a treatment drug for multiple sclerosis, with the trade name of Copaxone Originally a powder injection formulation, it was changed to injection in 2002 Last year, Teva again passed the FDA approval to launch a long-term Copaxone in the US market The change from once a day to three times a week increased the patient's compliance and was widely welcomed The generic Copaxone patent also expires this year Novartis seized the opportunity and prepared ahead of time This month, Novartis passed the FDA's approval and launched its own general-purpose gratemide acetate In fact, we can see why Novartis made such a choice from the following table We can see that since its launch, Copaxone's annual sales have been rising, especially since 2011, when it soared to about $3 billion, ranking firmly in the top 20 of the North American drug sales list It's no wonder that Novartis, famous for its original drugs, is also fond of Copaxone's generic drugs But generics are not that simple As early as 2014, Novartis and Teva had a lawsuit about the expiry date of Copaxone patent Teva, as a large generic drug owner, has not perfect patent protection for its original drugs In particular, the launch of long-acting Copaxone last year is also intended to continue to dominate the market of multiple sclerosis treatment drugs after the expiration of the original patent Despite the difficulties, Novartis is determined to carry out the imitation of grateme acetate, which is focused on its huge market value and hopes to take a share in the market of multiple sclerosis treatment It is not hard to see from the above events that even large international pharmaceutical companies attach great importance to generic pharmaceutical projects As far as the current situation of China's pharmaceutical industry is concerned, through years of accumulation and talent training, both in the field of chemical synthesis and biotechnology, there are a group of high-tech talents, which has laid a technical foundation for the development of new drugs in China But at present, the whole industry still has the situation of scattered technical strength and capital investment Although the state has been emphasizing in recent years, it is also encouraging original innovation But the development of innovative drugs is by no means an overnight success Enterprises need to survive and develop in the market competition, and they must launch products with market competitiveness When the original drugs can not be achieved in a short time, generic drugs are still a "shortcut" for the development of major pharmaceutical enterprises For many large and medium-sized pharmaceutical enterprises in China, generic drugs do not have too big technical barriers In addition to their own technical strength, they can also greatly strengthen their technical strength through flexible cooperation with relevant universities and research institutes What is the real challenge? In 2013 alone, there were 55 heavyweight drug varieties with sales of more than US $1 billion in North America It may be the first difficult problem for enterprises to develop generic drugs at this stage to take which variety as the target It may be the best way to solve this problem by using various professional database systems on the current market and network, tracking the research and development trends and market situation of generic drugs at home and abroad at any time, and establishing the target of generic drugs The above article is the author's personal opinion and does not represent the position of this website The intellectual property rights of the published content belong to yaozhi.com If you need to reprint, please indicate the source and the link of this article.