Introduction: Biosimilars have improved access to biologic medicines; however, historical thinking may jeopardize the viability of future markets.
Areas Covered: An expert panel of eight diverse European stakeholders provided insights about rethinking biosimilars and cost-savings, reducing patient access inequalities, increasing inter-market equity, and improving education. The insights reported here (Part 2) follow a study that provides perspectives on leveraging the holistic benefits of biosimilars for market sustainability based on independent survey results and telephone interviews of stakeholders from diverse biosimilar markets (Part 1). Directional recommendations are provided for payers.
Expert Opinion: The panel's market maturity framework for biosimilars has three stages: 'Invest,' 'Expand' and 'Harvest.' Across market stages, re-thinking the benefits of biosimilars beyond cost-savings, considering earlier or expanded access/new indications, product innovations, and re-investment of biosimilar-generated cost-savings should be communicated to stakeholders to promote further engagement. During 'Expand' and 'Harvest' stages, development of efficient, forward-looking procurement systems and mechanisms that drive uptake and stabilize competition between manufacturers are key. Future biosimilars will target various therapy areas beyond those targeted by existing biosimilars. To ensure a healthy, accessible future market, stakeholders must align their objectives, communicate, collaborate, and coordinate via education, incentivization, and procurement, to maximize the totality of benefits.
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http://dx.doi.org/10.1080/14737167.2024.2310684 | DOI Listing |
Front Public Health
December 2024
Vanke School of Public Health, Tsinghua University, Beijing, China.
Background: As China is one of the countries with the highest recorded cases of Immune-Mediated Inflammatory Diseases (IMIDs), these diseases have also emerged as a serious public health concern. Biosimilars, potentially lower-cost versions of biologics, may improve access to more affordable yet comparably effective treatments. Encouragingly, China launched its abbreviated biosimilar pathway in 2015, and since then, a large number of biosimilars have been approved.
View Article and Find Full Text PDFAntib Ther
October 2024
Product Development, Catalent Pharma Solutions, 14 School House Rd, Somerset, NJ 08873, United States.
Background: Formulation screening is essential to experimentally balance stability and viscosity in high-concentration mAb formulations. We developed a high-throughput approach with automated sample preparation and analytical workflows to enable the integrated assessment of excipient compatibility and viscosity of mAb formulations.
Methods: Ninety-six formulations of a trastuzumab biosimilar were screened by combining 8 types of excipient modifiers with 4 types of buffers across a pH range of 4.
Farm Hosp
December 2024
Hospital Universitario Doctor Peset, Valencia, Spain. Electronic address:
Introduction: Rheumatoid arthritis (RA) is the most common chronic inflammatory rheumatic disease, its management and morbidity impose a great burden to healthcare systems. Development and rollout of biological disease modifying anti-rheumatic drugs has contributed to improvements for patients, however, high costs have prevented them to be widely used. This is being addressed with biosimilars, with equal benefit-risk profile and reduced costs.
View Article and Find Full Text PDFJAMA Health Forum
December 2024
Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Diabetes Obes Metab
December 2024
College of Medicine, California Northstate University College of Medicine, Elk Grove, California, USA.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are at the forefront of treating the global health crisis of diabetes mellitus (DM) and obesity. However, the demand for GLP-1 RAs has far outstripped its supply and comes with a high monthly cost. Thus, the development of GLP-1 RA biosimilars can potentially address these barriers by providing greater access to medications that provide clinical outcomes similar to those of the reference products.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!