Biosimilars in Europe

• Other Authors: Vulto, Arnold G. (Editor), Simoens, Steven (Editor), Huys, Isabelle (Editor)
• Format: Electronic Book Chapter
• Language: English
• Published: Basel MDPI - Multidisciplinary Digital Publishing Institute 2023
• Subjects: Medicine; Pharmaceutical industries; infliximab; etanercept; TNFα inhibitors; biologics; biosimilars; Germany; policies; incentives; uptake; market dynamics; biosimilar market; biosimilar/supply and distribution; biosimilar sustainability; Delphi technique; pricing; reimbursement; utilization; biosimilar; biological; information; education; communication; patient; Europe; adalimumab; biosimilarity assessment; quality attributes (QAs); potentially critical quality attributes (pCQAs); European public assessment reports (EPARs); clinical governance; Spain; barriers; regulatory; review; approval; clinical; queries; regulatory science; budget impact analysis; savings; pharmaceutical spending; cost containment; reference biological; competitive market; Belgium; trastuzumab; intravenous; subcutaneous; HER2-positive breast cancer; drug costs; healthcare costs; cost simulation; tender; procurement; off-patent; award criteria; switching; interchangeability; sustainability; competition; n/a
• Online Access: DOAB: download the publication; DOAB: description of the publication

This reprint examines regulatory, pricing and reimbursement issues related to the market access and uptake of off-patent biologics, biosimilars, next-generation biologics and competing innovative medicines in European countries.