Biosimilar drugs, you succeeded in attracting my attention
The current situation of biosimilar drugs is getting better and better. A large number of clinical experimental data show that biosimilar drugs are safe and effective, and they are more and more accepted by all parties. For outsiders, you may not know about biosimilar drugs. In fact, biosimilar drugs are also called biosimilars, and they are biosimilars similar to approved biosimilars. The first biosimilar drug was approved for marketing in the European Union in April 2006. After extensive publicity and understanding, the biosimilar drugs developed rapidly.
As in 2016, there have been some major events in the biosimilars industry last year. Such as Medicare and Medicaid Services revised Medicare supplemental medical insurance (Part B) and prescription drug plans (Part D), FDA published draft principles similar biological drug interchangeability guide, Abbvie with Amgen patent litigation settlement Pfizer sued Johnson & Johnson unfair competition, and the Federal Trade Commission held anti-monopoly seminars. These events have promoted the development of the biosimilar drug industry to a certain extent, and also brought challenges to the industry.
When talking about the “challenge†label, at the 2017 Global Biosimilars Conference in Europe, delegates said that the current biosimilars field faces the following challenges: strict regulatory requirements, continued education for patients and doctors, original research drugs and Switching between biosimilars, understanding competitors' movements, and the structure of portfolios. From this point of view, there are still many problems to be solved in the field of biosimilar drugs that want to go smoothly.
In addition, in the pharmaceutical companies, some experts analyzed that compared with 2013-2015 is the concentrated expiration time of non-monoclonal biopharmaceutical patents, 2016-2020 is the peak of patent expiration of the monoclonal biopharmaceuticals, globally The big market for biosimilar drugs is coming soon. Pharmaceutical companies at home and abroad have already sniffed business opportunities and have accumulated their energy and prepared to do a big job. For example, domestic Fuhong Hanlin, CITIC Guojian, Cinda Bio, etc., foreign Amgen, Novartis (Sandez), Pfizer, etc.
From the perspective of the development of major companies, biosimilar drug research and development focused on adalimumab, infliximab, rituximab, bevacizumab, trastuzumab and other patents have expired or will soon expire The large variety of monoclonal antibodies. It is estimated that the global biosimilar drug market will reach $35 billion in 2020.
From this point of view, "promising prospects" is a big label for biopharmaceuticals. The author also learned about the trend of biosimilar drugs worthy of attention this year. First, companies still need to address the uncertainty and fear of public use of biosimilars. Although the situation of biosimilar drugs has developed well, many people still do not understand biosimilar drugs, and they are still in a stage of suspicion. In this regard, the industry said that the way pharmaceutical companies solve this problem is to lay the foundation for the introduction of biosimilar drugs. It's not enough just to go through the product description or hope that the doctor can prescribe it.
Secondly, there are no new companies in Latin America, Asia, the Middle East and North Africa. There are potential enterprises in these emerging markets. If the pharmaceutical companies can successfully enter these markets, the market benefits and future prospects will be It is good.
Finally, some new trends in biosimilars that experts have expressed concern include the new CMS hospital outpatient prepaid payment system rules and the B-part biosimilars how to reimburse under 340B. Some experts believe that ensuring the sustainable development of biosimilar drugs will still be an important and complex task. In the pre-market stage, companies will continue to seek more effective biosimilar drug development and regulatory processes. In addition, biosimilar drugs will play an important role not only in the field of rheumatology but also in the field of oncology. Therefore, it can be used in combination with expensive new drugs, thereby reducing the cost of treatment.
With the rapid development of the biosimilar drug industry and the expiration of the original drug patents, new targets, new technologies and new treatments will appear, and more and more biosimilar drugs will enter people's field of vision. Experts suggest that the target companies of biopharmaceuticals have relatively high valuations and levels, with a focus on the continuous innovation capability of technology and the core competitiveness of enterprises, such as branding, marketing and production. Therefore, like other industries, biosimilars must continue to innovate and improve technology.
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