Proposed policies to maximize societal benefit of biosimilars Posted 06/03/2020

During the European Commission’s (EC) fifth workshop on biosimilars, which was held in Brussels, Belgium on 30 October 2019, the subject of what policies might maximize the benefit of biosimilars to societies across Europe was discussed [1].
In his presentation, Zoltán Kaló, Professor of Health Economics at the Center for Health Technology Assessment, Semmelweis University and the Syreon Research Institute, gave a list of proposed policies that might maximize the societal benefit of biosimilars. These policies were grouped into regulatory and public administration of biosimilars, clinical guidelines, financing protocols and managed care, and patient education. The policies proposed by Professor Kaló included:
Regulatory and public administration of biosimilars
Clinical guidelines, financing protocols and managed care
Patient education Professor Kaló concluded that, as well as the policies proposed above, national targets are needed in order to optimize the benefits of biosimilars for society.
Related articles EC workshop on biosimilars focusses on sustainability
Reference Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.
• Expedited price and reimbursement process to facilitate timely market entry
• Administrative tools and policy measures to incentivize use of more affordable biosimilars
• Acceptance of international data generated in other EU Member States based on existing or new information exchange platform among regulators
• Amendment of clinical guidelines to allow earlier or extended use of more affordable biologicals, if health benefit is proven for the new patient population
• Multisource biologicals should be first-line biological therapy for all patients. More expensive patented biologicals with no proven significant clinical benefit compared to biosimilars should only be second-line options
• Single switch of patients from originator biological to more affordable biosimilar alternative under medical supervision should be mandated after patent expiry
• No separate reimbursement categories for: 1) biosimilars; and 2) originator biological or its modified formulation, e.g. subcutaneous vs intravenous, unless the modified formulation has proven benefits to patients or healthcare payers
• Physicians should not only be informed about scientific evidence on biosimilars but also given guidance on how to appropriately educate their patients on these medicines
Optimizing the benefits of biosimilars for society
1. European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Multi-stakeholder workshop on biosimilar medicinal products; 30 October 2019; Brussels, Belgium.
Comments (0)
Generics News Research General
- The role of authorized generics in Improving a...Generics/Research | Posted 05/03/2021
- Opportunities for generics with Korean patent e...Generics/General | Posted 05/03/2021
- Approving generics of polymer-based parenteral...Generics/Research | Posted 26/02/2021
- AIFA updates the Transparency Lists for genericsGenerics/General | Posted 26/02/2021
Biosimilars News Research General
- Biosimilar patent litigation trends in the USBiosimilars/General | Posted 05/03/2021
- Biosimilars approved in the USBiosimilars/General | Posted 14/08/2015
- Different approaches to the interchangeability...Biosimilars/Research | Posted 05/03/2021
- Efficacy and safety of interferon beta-1a (Reci...Biosimilars/Research | Posted 05/03/2021