Journal Article

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

Ji Hoon Jeong, Stefan Schreiber, JongHyuk Lee, Ben Parker, Laurent Peyrin-Biroulet, Rieke Alten, Peter M. Irving, Axel Dignass, HoUng Kim, Jonas Halfvarson, Luisa Avedano, Steven Simoens, Jørgen Jahnsen, Peter L. Lakatos, Silvio Danese, Rene Westhovens, Souzi Makri, Fernando Gomollón, Kay Greveson

2020

Overview

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.

• Publisher: Springer Science and Business Media LLC,Springer International Publishing,Springer Nature B.V,Springer Verlag
• Subject: [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology / [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system / [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology / [SDV]Life Sciences [q-bio] / Arthritis / Arthritis, Rheumatoid / Biological effects / Biological products / Biosimilar Pharmaceuticals / BOWEL-DISEASE / Clinical trials / CLINICAL-PRACTICE GUIDELINES / Collaboration / Cost control / Crohn's disease / CT-P13 INDUCTION THERAPY / ddc:610 / EARLY BIOLOGIC TREATMENT / ECONOMIC-IMPACT / Economics / EVIDENCE-BASED CONSENSUS / FDA approval / Human health and pathology / Humans / Hépatology and Gastroenterology / Inflammatory bowel disease / Inflammatory Bowel Diseases / Inflammatory diseases / Internal Medicine / Intestine / Leading / Leading Article / Life Sciences / Life Sciences & Biomedicine / Market entry / Markets / Maximization / Medical treatment / Medicine / Medicine & Public Health / NECROSIS FACTOR THERAPY / Nocebos / Optimization / Patients / PEDIATRIC CROHNS-DISEASE / Pharmacoeconomics / Pharmacology / Pharmacology & Pharmacy / Pharmacology/Toxicology / Pharmacotherapy / Pharmacovigilance / Physicians / Proteins / Quality / Regulatory approval / Response rates / Rheumatoid arthritis / RHEUMATOID-ARTHRITIS PATIENTS / Rhumatology and musculoskeletal system / Safety / Science & Technology / Studies / Supply chains / System effectiveness / Toxicology / ULCERATIVE-COLITIS