Although everyone admits that biosimilars are not like chemical generics and are difficult to be exactly the same as the original drugs, the idea still continues the idea of ??chemical generics, considering how to simplify the application and how to achieve freedom. Substitution, how to convince doctors and patients that generic drugs are as effective as original drugs. However, simple application, free substitution, and the same effect as the original drug are essentially the characteristics of chemical generic drugs. Now, biosimilars are facing new problems: how to make them and how to sell them. Pursue being able to make it, but not pursuing it to be exactly the same as the original drug, as long as it ensures safety and has its own efficacy; pursuing selling, but not pursuing free substitution approved by the drug regulatory department, nor wishful thinking that it can Make doctors and patients ignore the differences with the original drug.
In other words, some of the advantages of chemical generics are no longer available to biosimilars, but biosimilars have unique opportunities compared to chemical generics. In the past, because there were no technical barriers to imitating chemical drugs, once the patent expired, disorderly competition among a large number of pharmaceutical companies immediately formed. This naturally resulted in everyone only being able to obtain a meager average market profit; and because we were at the peak of technology, During this period, the research and development of new drugs was rapid, and patented pharmaceutical companies had new profit growth points. After the patents of chemical drugs expired, they took the initiative to significantly reduce the price, making the relevant market unprofitable. Now, these two factors are changing. Biosimilars are technically very difficult and have high barriers. There will be orderly competition for a long time, and industry profits will not drop suddenly; patent pharmaceutical companies There are no heavyweight new drugs, and there will be no rush to lower prices, and it will not be able to effectively attack opponents.
In addition, compared with the research and development of new drugs, biosimilars have more prominent advantages. As we all know, in terms of technology cycles, the rapid development period of biotechnology has passed, and it is still unknown when the next cycle will come. The current risks of new drug research and development are much greater than before. Although biosimilars are difficult, they are imitations after all. Manufacturers have already made them, and the possibility of the product has been proven. The risk of further research and development is much smaller. Reva Pharma estimates that the compound annual growth rate of biosimilars in the next few years is expected to reach 25%, while the annual growth rate of patented drugs can only maintain about 10%.
The biggest advantage of biosimilars over the original drugs that already exist on the market is that they are cheap (the pricing of patented drugs is often extremely crazy), which allows them to seize some of the original drug market and compete with the original drug manufacturers. Form direct competition, and constantly improve their technical level and marketing level in the competition. More importantly, this kind of competition can expand the entire market, make medicines affordable for people who could not afford them before, and make it possible to get varieties that were previously impossible to be covered by medical insurance.
When many Chinese companies make biopharmaceuticals, they want to make me better. In fact, it is not necessary. On the premise of ensuring basic effects and safety, the first thing they should care about is me cheaper. Technically speaking, it is very difficult to develop varieties that are more effective than the original drugs when much information about the original drugs is kept confidential. In the research and development process, it is still very promising to find ways to reduce research and development costs and make it cheaper. In the marketing process, we must completely abandon the sales model of chemical generic drugs, spend a lot of energy and time on the academic introduction and promotion of drugs, and even establish our own brand. Through academic promotion, doctors and patients can understand the effects of generic drugs and the differences between them and original drugs, so that they can make optimal drug choices based on actual conditions. China rarely has patented chemical drugs, but many companies have their own branded drugs. The past sales experience of branded drugs will also be of great help to the future sales of biosimilar drugs.
In China, there are currently only a few people with experience in biopharmaceutical research and development. There are some pharmaceutical companies that are excellent in all aspects, but lack experience in biopharmaceutical generics. The wave of biosimilars has just begun, and there is no major progress in new bio-patented drugs. Under such circumstances, it is not too late to enter the field of biopharmaceuticals. As long as the direction is clear and funds are in place, it is not difficult to achieve a breakthrough in biosimilar technology.
However, when an opportunity comes, you must dare to rush and seize it as soon as possible. Otherwise, you will lose not only the present, but the entire future!
On November 25, 2011, guests from Sanofi-Aventis, Sinopharm, Jiahe Biologics and other companies will discuss the development, cooperation and development of Chinese companies in this wave of biosimilars. Marketing strategies and possible clinical trial requirements for biosimilars by former FDA officials. The "2011 Biosimilars Summit Forum" was jointly hosted by China Bioengineering Magazine and BioValley. It not only grasped the development strategy of biosimilars from a macro perspective, but also explored the technical characteristics of biosimilars research and development as much as possible, thereby providing China with The development of the biosimilar drug industry provides some reference ideas.