Ab1568-HPR Interchangeability and Controversies in the Biosimilars Use: Brazilian Rheumatologists and Gastroenterologists Opinion

Background: Physicians need to be increasingly informed about biosimilars in order to participate efficiently and safely in the introduction of these new drugs[1]. A questionnaire of questions on biosimilar interchangeability, to assess the knowledge and positioning of rheumatology and gastroenterology physicians, was conducted by the Brazilian Society of Rheumatology (SBR) and the Brazilian Study Group of Inflammatory Bowel Disease (GEDIIB). Objectives: This study evaluated the knowledge and position of Brazilian rheumatologists and gastroenterologists about biosimilars. Methods: Analysis of the response to questionnaire on respondents' sociodemographic data, concepts and prescription of biosimilars, and degree of satisfaction regarding scientific information received by the Brazilian Society of Rheumatology (SBR), Brazilian Inflammatory Bowel Disease Study Group (GEDIIB) and manufacturers of these drugs. Inventory answered in September 2022 through the GoogleForms platform. Results: The sample contemplated 347 respondents rheumatologists (59.6%) and gastroenterologists (40.4%). The median age was 46 (38-60) years with 60% living in the southeastern region of Brazil. Most respondents (84.3%) would prescribe a biosimilar. Among non-prescribers, the main reason given in both specialties was lack of confidence in these medications (67.2%), followed by lack of non-inferiority clinical studies (38.2%) and scarcity of information (36.4%). The main reasons for prescription were proof of efficacy, safety and lower cost (30.3%) followed by availability by the health manager (23.3%). Patients who had not received immunobiological treatment before were the group of choice for the use of biosimilars (68.8%) for respondents. One hundred and twenty-six (60.6%) rheumatologists are in agreement with the exchange between biosimilars of the same molecula, however only 60 (43.2%) gastroenterologists are in agreement with the exchange (p<0.001). The ideal time to switch from the originator to the biosimilar was when the patient was stable or with the disease under control (59.1%). It was observed that 27.6% of the interviewees avoid making the switch, and most (64.2%) do not agree with the automatic switch without their prior consent. The specialists base their conduct on guidelines from SBR (49.0%), GEDIIB (36.8%), ANVISA (18.1%), FDA (19.0%) and EMA(16.3%). However, the majority of respondents (57%) are dissatisfied with the information received in scientific update channels and through manufacturers. Only 44 respondents (12.7%) are satisfied with the transparency in the production process of these drugs. Conclusion: Evaluation of the experts' opinion was important for us to know the main doubts, questions and positioning regarding biosimilars. It is noteworthy that the main reasons for not prescribing biosimilars were the lack of confidence and information. REFERENCES: [1] Guidelines on evaluation of biosimilars. Repacement of Annex 2 of WHO Technical Report series, N:977. World Health Organization 2022. Available online: https://www.who.int/publications/m/item/guidelines-on-evaluation-of-biosimilars. Acesso em junho 2023. Acknowledgements: NIL. Disclosure of Interests: Fabiana Moura Received fee to give lectures to healthcare professionals, Rafaela Bicalho Viana Macedo Received fee to give lectures to healthcare professionals, Antônio Boechat: None declared, Michel Yazbek Received fee to give lectures to healthcare professionals, Juliana Cabrera Garrido Received fee to give lectures to healthcare professionals, Paulo Chicarone Pereira: None declared, Alexandre Uehbe Received fee to give lectures to healthcare professionals, Julio Moraes: None declared, Ricardo Machado Xavier Received fee to give lectures to healthcare professionals, Hellen Mary da Silveira de Carvalho Received fee to give lectures to healthcare professionals, Received fees for consulting for the pharmaceutical industry, Amanda MArques: None declared, Tiago Gomez: None declared, Francisco Airton Rocha: None declared, Fabiana Pina Received fee to give lectures to healthcare professionals, Valderílio Azevedo Received fee to give lectures to healthcare professionals.