OP0013 PARE AFLAR’S – FRENCH LEAGUE AGAINST RHEUMATISM –POSITION AND PATIENT INFORMATION ACTION ABOUT BIOSIMILAR MEDICINES IN FRANCE
Authors: Laurence Carton, Claire Cardon, Francoise Alliot Launois, Gerard Chales, Brigitte Liesse, Laurent Grange
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> 20 years after biotherapies were introduced in rheumatic diseases treatment in France, biosimilars are a new medical and economic issue in terms of therapeutic opportunities, and innovative treatment spreading and development. Patients’ rights - quality of life, information on treatment and safety - as well as public health cost management, medical and other caregivers ‘practices are involved. <h3>Objectives</h3> AFLAR wants to play an active role in these fields, as about one million of patients with inflammatory rheumatic diseases, and next other diseases, are concerned. <h3>Methods</h3> AFLAR’s patient led board (1), medical and scientific experts and especially expert patients have been working together to: state AFLAR’s position about biosimilars define the most adapted association’s actions in the field of biosimilars create the most proper tool to inform and empower patients to their rights, especially in the field of treatment efficacy and safety. <h3>Results</h3> A position paper leading to a press release dated Dec. 7th, 2018 prior to national rheumatology medical congress opening has been achieved. An informative tool to be used for shared medical decision when biosimilars are involved, is currently in progress. AFLAR’S position on biosimilars includes 2 statements and 6 advices addressed to patients, caregivers and other stakeholders: <h3>Statements</h3> Biosimilars are a medical and healthcare cost reduction effective solution in rheumatic diseases treatment; Biosimilars have scientifically proved their efficacy and safety in past and ongoing studies; drug safety monitoring is ensured by national and European drug safety agencies. <h3>Advices</h3> Further continuous clinical post–marketing studies should be achieved, and their results easily available to patients. Patient should be properly informed each time a biosimilar is proposed if has not been tested versus original biotherapy in his/her own specific disease Biosimilar drug can be prescribed for cost reduction reason as initial biotherapy treatment, when not contraindicated Blind random switch from originator to biosimilar and among biosimilar products should not be done, based on precautionary principle Patient should be precisely informed of product with biosimilar name (not only international non–proprietary name), and batch number, as this allows mandatory pharmacovigilance by professionals and patients. As per law (2) and professional ethics, patient preference and right to informed consent must prevail. Self–assessment surveys, and patient reported outcomes using studies, should be encouraged. These are facilitated by new information technologies practices and devices. <h3>Conclusion</h3> The information tool will be proposed in the form of an information letter to be remitted by professionals to patient when biosimilar prescription or initiation is planned. The process includes: creation of document by expert patients user testing of tool (assessment about understandability and usefulness), in hospital departments, patient groups and on–line knowledge assessment and opinion gathering among patients about biosimilars. <h3>References</h3> [1] According to its current by-laws, AFLAR board consists of at least 2/3 of persons affected with/concerned by rheumatic diseases, and/or presidents of affiliated patient associations. [2] Articles L1111-2 and L2002-303 Code de Santé Publique <h3>Acknowledgement</h3> thank you to the patients and associations of French patients having given their opinion on this topic <h3>Disclosure of Interests</h3> Laurence Carton Grant/research support from: AMGEN UCB MYLAN BIOGARAN BIOGEN PFIZER LILLY GRUNENTHAL TEVA NOVARTIS JANSSEN EXPANSCIENCE SANOFI THUASNE MSD GENEVRIER ABBVIE, Claire Cardon Grant/research support from: AMGEN UCB MYLAN BIOGARAN BIOGEN PFIZER LILLY GRUNENTHAL TEVA NOVARTIS JANSSEN EXPANSCIENCE SANOFI THUASNE MSD GENEVRIER ABBVIE, Francoise Alliot Launois: None declared, Gerard Chales Grant/research support from: AMGEN UCB MYLAN BIOGARAN BIOGEN PFIZER LILLY GRUNENTHAL TEVA NOVARTIS JANSSEN EXPANSCIENCE SANOFI THUASNE MSD GENEVRIER ABBVIE, Brigitte Liesse Grant/research support from: AMGEN UCB MYLAN BIOGARAN BIOGEN PFIZER LILLY GRUNENTHAL TEVA NOVARTIS JANSSEN EXPANSCIENCE SANOFI THUASNE MSD GENEVRIER ABBVIE, LAURENT GRANGE Consultant for: Laurent Grange has received honoraria from Amgen, Lilly and UCB and research support from Lilly, Amgen, UCB, Expanscience, Mylan, Roche diagnostics and TEVA