Biologicals, you've got my attention

[market analysis of chinapharma.com] the current situation of bio similar drugs is getting better and better A large number of clinical experimental data show that bio similar drugs are safe and effective, and they are increasingly accepted by all parties The layman may not know about biological similar drugs In fact, biological similar drugs are also known as biological generic drugs, which are similar to the approved biological original drugs Biological analogues were approved by the European Union in April 2006 After extensive publicity and understanding, biological analogues developed rapidly As in 2016, there have been some major events in the biomedical industry in the past year For example, the federal medical insurance and Medicaid Service Center revised the Medicare supplementary medical insurance (Part B) and prescription drug plan (Part D), FDA issued the draft guidelines for interchangeability of biological similar drugs, Alberta and Amgen litigation reached a settlement, Pfizer sued Johnson and Johnson for unfair competition, the Federal Trade Commission held an antitrust seminar, etc To some extent, these events have promoted the development of similar biological medicine industry, and also brought challenges to the industry Referring to the "challenge" label, at the 2017 Global Conference on bioequivalent drugs in Europe, delegates at the conference said that at present, the field of bioequivalent drugs mainly faces the following challenges: strict regulatory requirements, continued education for patients and doctors, switching between original research drugs and bioequivalent drugs, understanding the trend of competitors, and the structure of investment portfolio Therefore, there are still many problems to be solved in the field of biological similar drugs In addition, in terms of pharmaceutical enterprises, experts have analyzed that compared with 2013-2015, the period from 2016 to 2020 is the peak of the expiry of non McAb biological drugs, and the global market of biological similar drugs is coming Drug companies at home and abroad have already smelled the business opportunities, and they have accumulated physical strength and are ready to do a big job For example, domestic Fuhong Hanlin, CITIC Guojian, Cinda biology, etc., and foreign Amgen, Novartis, Pfizer, etc From the perspective of the development of major companies, the research and development of bio similar drugs focus on the large varieties of monoclonal antibodies that have expired or are about to expire, such as adalimumab, infliximab, rituximab, bevacizumab and trastuzumab It is estimated that in 2020, the global market space for bio similar drugs will reach US $35 billion From this point of view, "promising future" is also a major label of Biopharmaceutics, and the author also understands the trend of biopharmaceuticals worth paying attention to this year from relevant aspects First, companies still need to address the uncertainty and fear of public use of biologicals Although the development of biological analogues is better, many people do not know about biological analogues and are still in the stage of doubt To this end, the industry said that the way for pharmaceutical companies to solve this problem is to lay the foundation for the introduction of bio similar drugs It's not enough just to explain the product or to hope that doctors can prescribe a prescription Secondly, the new markets in Latin America, Asia, the Middle East and North Africa haven't been explored in depth There are huge potential values in these emerging markets If pharmaceutical companies can successfully enter these markets, the market benefits and future prospects will be good Later, some experts said that the new trend of bio similar drugs that need attention also includes the new CMS hospital outpatient prepayment system rules, as well as the provisions on how Part B bio similar drugs can be reimbursed under the 340B clause Some experts also believe that it will still be an important and complex task to ensure the sustainable development of bioequivalent drugs In the pre IPO stage, enterprises will continue to seek more effective research and development and regulatory processes of bioequivalent drugs In addition, biological analogues will play an important role not only in the field of Rheumatology, but also in the field of oncology Therefore, it can be combined with expensive new drugs to reduce the cost of treatment With the rapid development of bio similar medicine industry and the expiration of the original drugs, more and more bio similar drugs will come into people's vision with the emergence of new targets, new technologies and new treatment methods Experts suggest that the target enterprises of Biopharmaceutics have relatively high valuation and level The key point is the continuous innovation ability of technology and the core competitiveness of enterprises, such as brand, marketing and production Therefore, like other industries, bio similar pharmaceutical industry should continue to innovate and improve technology.