Biological analogues will be the next gold mine

Source: touhu.com.cn 2016-04-11 has unlimited market potential from 2011 to 2017, which is another peak period for the expiration of brand name drug patents in the world pharmaceutical history Some large multinational pharmaceutical companies successively have more than half of the $77 billion worth of drug patents expired, and the new medical reform in the United States will consume about 1 in the next 10 years Trillion dollars, both of which stimulate the sensitive nerves of pharmaceutical enterprises However, restricted by the research and development technology of new drugs and the first imitation policies of various countries, although the market of generic drugs is vast, it is still difficult for relevant enterprises to enjoy the "sweet soup of generic drugs" However, more and more pharmaceutical companies begin to turn their attention to the bio similar drug market Such as zarxio, REMICADE, the subsidiaries of Novartis, whose global sales reached 8.4 billion US dollars in 2013, SB2 (REMICADE), Sb3 (Herceptin), Sb4 (Enbrel), sb5 (Humira), mk-1293 (Lantus), yevoy, opdivo, Erbitux Foreign companies with strong strength, such as CITIC Guojian, Beida, Huahai, Haizheng, Hengrui, Lizhu, Renfu, Hualan and other local enterprises with the ability to develop biopharmaceuticals, are also striving for the similar biopharmaceutical market For many pharmaceutical companies to make such efforts in the market of biological similar drugs, in fact, it has nothing to do with the encouragement of relevant policies Taking China as an example, on February 28, 2015, CFDA drug review center (CDE) issued the technical guidelines for research, development and evaluation of biological similar drugs (Trial) The regulatory framework of biopharmaceuticals has been established, which provides another way for biopharmaceuticals to be listed in China Similar to the regulatory authorities in the United States and the European Union, China's CDE also expects pharmaceutical companies to submit detailed structural and functional characteristics of similar biological drugs for comparison with reference drugs In addition, CDE also adopts a similar gradual approach to developed countries, and evaluates the similarity by comparing pharmacological data, non clinical research and clinical research In the same way, FDA issued a draft Labeling Guide for similar biological products on March 31, 2016 In the draft guidance, FDA explicitly states that the labeling of biosimilar products should not include descriptions of clinical studies that only support the clinically insignificant differences between the proposed biosimilar products and the reference products for the approved indications The promulgation of relevant policies of various countries has undoubtedly brought confidence to a large number of pharmaceutical enterprises to enter the market of biological similar drugs In fact, the reality is also moving towards the pharmaceutical companies entering the market of biological similar drugs According to the latest data, by 2020, only in Europe and the United States, the market of biological similar drugs will reach 110 billion US dollars With the expiration of patent drugs, biological similar drugs will occupy 20% of the market in the next five years It is expected that the price difference between related brand biological preparations and biological generic drugs will further increase Technology restricts the development of enterprises Although it seems that the prospect of biological similar drugs is good at present, the industry also reminds that it faces many challenges and risks in the future One is that the market of bio similar drugs is hindered Such as the resistance of biological original drug research enterprises In December 2015, Amgen announced to submit the biological product license application (BLA) of biological generic abp501 to the US FDA In fact, the drug is a biosimilars of HUMARA, a super heavyweight drug of Abercrombie This move is interpreted as the "Ai patent war" by the industry, which has a great impact on the market of aibwi Second, technological advantages need to be upgraded According to statistics, from the perspective of treatment, even in the largest share of immunostimulants and diabetes, there are only a few high-tech biologics, which are still dominated by low-tech biochemical drugs In terms of product categories, peptides and synthetic insulin, which account for the largest share, belong to low-tech products, while high-tech biological drugs such as monoclonal antibodies, account for a very limited proportion Therefore, the future development path of pharmaceutical enterprises is determined by the solution of bio similar drug related technologies Third, the price advantage is not obvious The development and production cost of biopharmaceuticals is much higher than that of chemical generic drugs According to relevant reports, the degree of profit depends mainly on the supervision of policies, but it is difficult to adopt low-cost strategy to occupy the market in the European and American mainstream market with strict supervision.