Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1001/jama.2022.24078 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Accelerating biosimilar market access: the case for allowing earlier standing.
J Law Biosci
January 2025
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 1620 Tremont St. Suite 3030, Boston, MA 02120, USA.
Biosimilars, which are affordable alternatives to biologic medicines, face delays in market entry due to the current patent litigation framework under the Biologic Price Competition and Innovation Act. Currently, biosimilar manufacturers can only initiate patent litigation to attempt to clear weak and invalid patents after submitting their Biologic License Application to the Food and Drug Administration (FDA), which happens after completing extensive, and costly clinical trials. By contrast, generic drug manufacturers can start litigation earlier due to shorter development times and less stringent clinical requirements, allowing them to launch immediately after the primary patent expires.
View Article and Find Full Text PDFRegulatory Framework for Supporting the Integration and Use of Biosimilars in the Private Healthcare System of the United Arab Emirates (UAE).
Cureus
November 2024
Health Economics, Semmelweis University, Center for Health Technology Assessment, Budapest, HUN.
Introduction Biologics are substantial in the treatment of different diseases; however, they can burden the healthcare systems due to their high cost. Biosimilars can help healthcare systems keep their financial sustainability and patients access to biological therapies. The research objective is to formulate a framework for integrating biosimilars in the private healthcare sector of the United Arab Emirates (UAE).
View Article and Find Full Text PDFUse of Public Research and Manufacturing Enterprises to Lower Prescription Drug Prices and Increase Innovation.
J Law Med Ethics
December 2024
WEST VIRGINIA UNIVERSITY COLLEGE OF LAW, MORGANTOWN, WEST VIRGINIA, USA.
This article proposes building on the success of publicly funded drug research and development and expanding the model to include the full cycle development, testing, manufacture and distribution of innovative and affordable new drugs.
View Article and Find Full Text PDFUS Trends In Anticancer Medicine Pricing And The Impact Of Competition, 2014-20.
Health Aff (Millwood)
December 2024
Danielle Rodin, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Prices of anticancer medicines (including chemically synthesized medicines and biologics manufactured from living organisms) are a subject of concern, as they contribute to spending by health plans and patients. We describe prices and evaluate the impact of competition among 185 anticancer medicines, using IQVIA data from the period October 2014-February 2020. We calculated the price of each medicine, defined as volume-weighted wholesale costs net of prompt-pay discounts and gross of rebates, without and with inflation adjustment, and summarized them by patent status, formulation, and therapeutic class.
View Article and Find Full Text PDFEconomic Evidence on Cost Sharing and Alternative Insurance Designs to Address Moral and Behavioral Hazards in High-Income Health Care Systems: A Systematic Review.
J Mark Access Health Policy
December 2024
Center for Value Based Insurance Design (V-BID), University of Michigan, Ann Arbor, MI 48109, USA;
In health insurance, "moral hazard" describes the concept that coverage without an out-of-pocket cost to consumers could result in health care utilization beyond economically efficient levels. In response, payers in the United States (US) have designed pharmaceutical benefit plans with significant cost exposure (e.g.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!