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The Future of Biosimilars : Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim, HoUng (author)
Celltrion Healthcare, Incheon, Republic of Korea; Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, Republic of Korea
Alten, Rieke (author)
Department of Internal Medicine and Rheumatology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany
Avedano, Luisa (author)
European Federation of Crohn’s and Ulcerative Colitis Associations, Brussels, Belgium
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Dignass, Axel (author)
Department of Medicine 1, Agaplesion Markus Hospital, Frankfurt am Main, Germany
Gomollon, Fernando (author)
Gastroenterology Unit, Clinical University Hospital Lozano Bless IIS Aragón, Zaragoza, Spain
Greveson, Kay (author)
Centre for Gastroenterology, Royal Free Hospital, London, UK
Halfvarson, Jonas, 1970- (author)
Örebro universitet,Institutionen för medicinska vetenskaper,Department of Gastroenterology
Irving, Peter M. (author)
IBD Centre, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
Jahnsen, Jørgen (author)
Department of Gastroenterology, Akershus University Hospital, Lørenskog, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway
Lakatos, Peter L. (author)
Division of Gastroenterology, McGill University, Montreal QC, Canada; 1st Department of Medicine, Semmelweis University, Budapest, Hungary
Lee, JongHyuk (author)
Department of Pharmaceutical Engineering, College of Life and Health Science, Hoseo University, Asan, Republic of Korea
Makri, Souzi (author)
Cyprus League Against Rheumatism, Nicosia, Cyprus
Parker, Ben (author)
Kellgren Centre for Rheumatology, NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK; Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
Peyrin-Biroulet, Laurent (author)
Inflammatory Bowel Disease Unit, Nancy University Hospital, Allée du Morvan, France
Schreiber, Stefan (author)
Department Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany
Simoens, Steven (author)
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
Westhovens, Rene (author)
Department of Development and Regeneration, Skeletal Biology and Engineering Research Center KU Leuven, Rheumatology University Hospital Leuven, Leuven, Belgium
Danese, Silvio (author)
Department of Gastroenterology, Istituto Clinico Humanitas, Milan, Italy
Jeong, Ji Hoon (author)
Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, Republic of Korea
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 (creator_code:org_t)
2020-01-30
2020
English.
In: Drugs. - : Adis International. - 0012-6667 .- 1179-1950. ; 80:2, s. 99-113
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)

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