Kim H^1,2, Alten R³, Avedano L⁴, Dignass A⁵, Gomollón F⁶, Greveson K⁷, Halfvarson J⁸, Irving PM⁹, Jahnsen J^10,11, Lakatos PL^12,13, Lee J¹⁴, Makri S¹⁵, Parker B^16,17, Peyrin-Biroulet L¹⁸, Schreiber S¹⁹, Simoens S²⁰, Westhovens R²¹, Danese S²², Jeong JH²³. Drugs. 2020 Jan 30. doi: 10.1007/s40265-020-01256-5. [Epub ahead of print]

Author information

1 Celltrion Healthcare, Incheon, Republic of Korea.

2 Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, Republic of Korea.

3 Department of Internal Medicine and Rheumatology, Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany.

4 European Federation of Crohn's and Ulcerative Colitis Associations, Brussels, Belgium.

5 Department of Medicine 1, Agaplesion Markus Hospital, Frankfurt am Main, Germany.

6 Gastroenterology Unit, Clinical University Hospital Lozano Bless IIS Aragón, Zaragoza, Spain.

7 Centre for Gastroenterology, Royal Free Hospital, London, UK.

8 Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.

9 IBD Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK.

10 Department of Gastroenterology, Akershus University Hospital, Lørenskog, Norway.

11 Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

12 Division of Gastroenterology, McGill University, Montreal, QC, Canada.

13 1st Department of Medicine, Semmelweis University, Budapest, Hungary.

14 Department of Pharmaceutical Engineering, College of Life and Health Science, Hoseo University, Asan, Republic of Korea.

15 Cyprus League Against Rheumatism, Nicosia, Cyprus.

16 Kellgren Centre for Rheumatology, NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.

17 Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.

18 Inflammatory Bowel Disease Unit, Nancy University Hospital, Allée du Morvan, France.

19 Department Medicine I, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.

20 Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

21 Department of Development and Regeneration, Skeletal Biology and Engineering Research Center KU Leuven, Rheumatology University Hospital Leuven, Leuven, Belgium.

22 Department of Gastroenterology, Istituto Clinico Humanitas, Milan, Italy. sdanese@hotmail.com.

23 Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, Republic of Korea. jhjeong3@cau.ac.kr.

Abstract

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.