Biosimilars, how far away are we?

original title: Biosimilar drugs, how far away from us
2018 ESMO Conference has been gorgeously closed, I believe that whether it is to the scene of the participants or small partners in the country, have drawn a lot of fresh nutrients from this academic feastIn fact, in addition to academic updates in various fields, the European Union, which has always been concerned about the ratio of drug cost to profitability and the availability of medicines, also arranged a biosimilar panel discussion at the conferenceThe main elements covered include: the definition of biosimilar drugs, why biosimilars are needed, the current situation and challenges of clinical application of biosimilars, the exodus and interchange of indications, and so onSeeing the efforts and advances from all sides, a path to be explored is also before usfaced with the coming wave of biosimilars, ESMO conducted a biosimilar awareness study from September to October 2017 to assess the current level of knowledge of oncologists in biosimilars, their understanding of the biosimilar development process, and their acceptance of clinical useThe ESMO symposium is an Easybiothesthetoaccess, inpractice? officially announced the results of the research (Existingchallenges foruptake of the ybiosimilars-ESMOsurveyresults) to share and think with you495 people surveyed, 67 per cent from Europe, 19 per cent from the Asia-Pacific region, 11 per cent from the United States and the remaining 3 per cent from AfricaThe questionnaire consisted of five sections with 19 questions:1 background check:concept of biosimilars, whether they were willing to prescribe approved biosimilars
79 per cent of people believed they had a medium to high level of biosimilar sin, and 78 per cent of respondents in Europe and 65 per cent in the Asia-Pacific region were able to correctly answer the definition of biosimilarsForty-nine percent of people use biosimilars (non-monoantigens) in routine treatment, and 50 percent have moderate or higher acceptance of biosimilarsIt can be seen that prescription doctors have a better basic knowledge of biosimilardrugs, but most people do not use them in daily practice2 Biosimilar Sin Research and Development:understanding of the process of biosimilar drug data
only 38% of people have a moderate level of understanding of the biosimilar drug development process (higher in the Asia-Pacific region), and 28% of people believe that when conducting comparative trials of the efficacy and safety of biosimilar drugs, it should be evaluated separately with the original drug in each adaptation certificate This result suggests that the promotion and education of biosimilar drug research and development concepts need to be further strengthened, especially around the important topic of adaptation certificate extrapolation 3 Indications Extrapolation: conceptual understanding, willingness to prescribe exoplanet seducoration 62% correctly understood the concept (82 people skipped the problem), 39% understood the topic of an indication (88 people skipped) Only 17 per cent of people were willing to use biosimilars in the external adaptation certificate It can be seen that although most people can theoretically understand the adaptation of the evidence extrapolation, in the practical application of the acceptance is still lacking Interchange and Drug Conversion: concerns and concerns about this concept
most prescribing physicians understand the concepts of drug swap, conversion, and substitution But they also expressed similar concerns about the potential adverse reactions and the increased risk of immunoogenic reactions from the original drug's swap with biosimilars The main concern for European doctors is the increased risk of immune responses, while at the same time there is a high degree of consensus that adverse reactions do not increase after drug conversion It can be seen that their ideas are contradictory, need to get more information about immunogenicity and drug conversion 5 education needs: 86.7 per cent expressed the hope that ESMO would conduct more educational training activities on biosimilar drugs (82.9 per cent in Europe and 97.9 per cent in the Asia-Pacific region) The main activities include face-to-face exchanges (e.g conference lectures, panel discussions, etc.), online training courses and materials European doctors are more interested in the efficacy and safety of biosimilars, while doctors in the Asia-Pacific region are more concerned about how developing countries are trained the general analysis shows that the level of knowledge of doctors about biosimilardrugs is encouraging, but there is still a huge demand for education and training among medical workers, nurses, patients and payers More data on drug conversion is needed in the future, including the conversion of primary drugs to biosimilars, the conversion of biosimilars to biosimilars, and, in individual cases, the conversion of biosimilars to primary drugs In addition, more needs to be done in the future to promote awareness of adaptation to evidence-dying We all know that macromolecule biologics (such as monoclonal antibodies) are highly complex, flexible and immunogenic, so the difference between copying small molecule drugs and macromolecule biologics is as great as making a bicycle and a spaceship And adaptation to the extrapolation, drug conversion and substitution is a very controversial topic In order to truly achieve optimal cancer sustainability treatment, the future development of biosimilars must be guided by rigorous scientific test design, high standards of regulatory approval, and the accumulation of long-term clinical practice experience Biosimilar drugs for China or the world, for medical workers, pharmaceutical companies or regulatory authorities are a relatively new concept, in front of a standardized first, prudent approach to exploration References: https://cslide.ctimeetingtech.com/library/esmo/browse/search/51E-2Ea2G06SMO-SMOCOLLOQUIUM-Arebiosimilarsthetatoaccess, inpractice?Existingchallengesforsfor takeofybiooncologs - ESMOsurveyresults Presenter: M.Vyas (Lugano, Switzerland) medical science oncology GI team pharmaceutical fusion copyright notice: This article is transferred from the internet, if you do not wish to be reproduced media or individuals can contact us, we will immediately delete