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Review
. 2020 Feb;80(2):99-113.
doi: 10.1007/s40265-020-01256-5.

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

HoUng Kim  1   2 , Rieke Alten  3 , Luisa Avedano  4 , Axel Dignass  5 , Fernando Gomollón  6 , Kay Greveson  7 , Jonas Halfvarson  8 , Peter M Irving  9 , Jørgen Jahnsen  10   11 , Péter L Lakatos  12   13 , JongHyuk Lee  14 , Souzi Makri  15 , Ben Parker  16   17 , Laurent Peyrin-Biroulet  18 , Stefan Schreiber  19 , Steven Simoens  20 , Rene Westhovens  21 , Silvio Danese  22 , Ji Hoon Jeong  23
Affiliations
Review

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

HoUng Kim et al. Drugs. 2020 Feb.

Erratum in

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.

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Conflict of interest statement

HK is employed by and holds stock options in Celltrion Healthcare Co., Ltd. LA has received financial support from Biogen for lectures; grants have been awarded to the European Federation of Crohn’s & Ulcerative Colitis Associations (for projects, advocacy activities, surveys) from Atlantic, AbbVie, Biogen, Celgene, Celltrion, Merck-MSD, Ferring, Janssen, Mundipharma, Otsuka, Pfizer, Shire, Takeda, Vifor, and Philips Morris International Foundation. AD has served as consultant for AbbVie, Celgene, Janssen, MSD, Pfizer, Roche, Sandoz/Hexal, Takeda, and Vifor; received payment for development of educational presentations from Falk Foundation, Ferring, Tillotts, and Takeda; received speaker fees from AbbVie, Falk Foundation, Ferring, Janssen, MSD, Pfizer, Vifor, and Takeda; received manuscript fees from Thieme and Wiley; and received research grants from Institut für Gemeinwohl and Stiftung Leben mit Krebs. FG has received financial support from AbbVie, Janssen, MSD, and Takeda for lectures and travel to scientific meetings. JH has received research grants from Janssen, MSD, and Takeda; served as a consultant and/or an advisory board member for AbbVie, Celgene, Celltrion, Ferring, Hospira, Janssen, Medivir, MSD, Novartis, Pfizer, Prometheus Laboratories Inc., Sandoz, Shire, Takeda, Tillots Pharma, and Vifor Pharma; and served as a speaker for AbbVie, Celgene, Ferring, Hospira, Janssen, MSD, Novartis, Pfizer, Sandoz, Shire, Takeda, Tillotts Pharma, and Vifor Pharma. PMI has received honoraria for acting in an advisory capacity from AbbVie, Celgene, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Prometheus, Samsung Bioepis, Sandoz, Takeda, Topivert, VH2, Vifor, and Warner Chilcott; received speaker fees from AbbVie, Falk Pharma, Ferring, Janssen, MSD, Pfizer, Sandoz, Shire, Takeda, Tillotts, and Warner Chilcott; and received research funding from MSD, Pfizer, and Takeda. JJ has served as a speaker, consultant, or advisory board member for AbbVie, Astro Pharma, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Ferring, Hikma, Janssen, Meda, MSD, Napp Pharma, Orion Pharma, Pfizer, Pharmacosmos, Roche, Takeda, Tillotts, and Sandoz. PLL has received consulting fees or lecture support from AbbVie, Celgene, Celltrion, Ferring, MSD, Pfizer, Roche, and Takeda and unrestricted research support from AbbVie, Pfizer, and Takeda. BP has received honoraria and speaker fees from AbbVie, AstraZeneca, Celltrion, GSK, Lilly, Pfizer, Roche, and UCB. LP-B has received consulting fees from AbbVie, Allergan, Alma, Amgen, Applied Molecular Transport, Arena, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Enterome, Ferring, Genentech, Gilead, Index Pharmaceuticals, Janssen, Lilly, MSD, Nestle, Oppilan Pharma, Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz, Sterna, Sublimity Therapeutics, Takeda, Tillotts, and Vifor; payment for lectures, including service on speakers bureaus, from AbbVie, Biogen, Celltrion, Ferring, Hikma, Janssen, MSD, Pfizer, Roche, Samsung Bioepis, Takeda, and Tillotts; grant/research support from AbbVie, MSD, and Takeda; and stock options from CT-SCOUT. Stefan Schreiber has received personal fees for participation on advisory boards from AbbVie, Arena, Biogen, Bristol-Myers Squibb, Celgene, Celltrion, IMAB, Falk, Fresenius, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist, Provention Bio, Takeda, and Theravance. Steven Simoens has conducted biosimilar research sponsored by Hospira (now Pfizer); was involved in a stakeholder roundtable on biosimilars sponsored by Amgen, MSD, and Pfizer; has participated in an advisory board meeting for Pfizer; and currently works with Amgen, Celltrion, Mundipharma, and Pfizer as a consultant to carry out biosimilar research. RW has acted as a principal investigator and advisor for Celltrion and Galapagos/Gilead and has given lectures for Celltrion. SD has received consulting fees or honorarium from AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring Pharmaceuticals Inc., Gilead, Hospira, Janssen, Johnson & Johnson, MSD, Mundipharma, and Pfizer. RA, KG, JHJ, JL, and SM have no conflicts of interest that are directly relevant to the content of this article.

Figures

Fig. 1
Fig. 1
Biologics licensed by the FDA and/or EMA for the treatment of RA and/or IBD as of 25 November 2019 (references are provided in Table S2 in the electronic supplementary material). TNF inhibitors are shown in black; biologics with other targets are shown in gray. For biologics shown in bold, biosimilars have been licensed by the FDA and/or the EMA in relevant indications. aLicensed by the FDA only. bLicensed by the FDA only for the treatment of Crohn’s disease. cThe intravenous form of golimumab (Simponi Aria®) is licensed by the FDA only, for the treatment of RA only. EMA European Medicines Agency, IBD inflammatory bowel disease, RA rheumatoid arthritis, TNF tumor necrosis factor
See this image and copyright information in PMC

References

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