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PP18 Horizon Scanning For Clinical Biosimilar Medicines: Informing The Lifecycle Of Health Technology Assessment And Market Access
- Amy Hussain, Ross Fairbairn, Dapo Ogunbayo
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, pp. S45-S46
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- Article
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Introduction
The National Institute for Health and Care Research (NIHR) Innovation Observatory (IO) national horizon scanning research centre, has a remit to notify its stakeholders, including the National Institute for Health and Care Excellence (NICE), about innovative interventions; including biosimilar medicines in the pipeline. Biosimilar medicines bypass many developmental steps, making them substantially cheaper to manufacture for providers, which increases market availability and improves treatment access for patients.
MethodsSince 2017, the NIHR IO has monitored biosimilars in clinical development that align to the NICE health technology assessment remit. The data set explored was exported from our internal medicines innovation database - MInD.
Data sets were created that included information on the characteristics of biosimilars and their associated clinical trials. Analyses and visualization creation were carried out using Microsoft Excel and Microsoft Power BI.
ResultsA total of 100 unique biosimilar medicines in 136 clinical trials were included in the MInD since April 2017. Of these, 44 percent of biosimilars are currently EMA-approved (Nov 2021). Adalimumab was the reference medicine with the most unique biosimilars identified (12%). Seventy-two percent of the biosimilars in MInD were indicated for non-oncology conditions, twenty percent for oncology condition and eight percent for both.
There were 46 biosimilars unapproved, which were in active development. Of these biosimilars 17.4 percent are indicated for an oncology condition, 78.3 percent for non-oncology conditions, and 4.3 percent for biosimilars for both. Aflibercept was the reference product with the most (eight) biosimilars in active development.
There were 56 individual clinical trials in the MInD that list a biosimilar in development. For 26 trials, the primary completion date (PCD) was prior to 2021, whilst 28 trials listed a PCD post-2021, and 2 PCD’s were unavailable
ConclusionsOur analysis identified high levels of active clinical development for biosimilars. The majority of biosimilars being developed are indicated for non-oncology conditions, with many in trials due to readout in the near future. Early identification, monitoring and reporting of biosimilars allows for expedited patient access and benefits, including cost-savings for health services.
This study is funded by the National Institute for Health Research (NIHR) [(HSRIC-2016-10009)/Innovation Observatory].
Rogues' Gallery of Contributing Authors
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- By Ramon Abola, Rishimani Adsumelli, Syed Azim, Tazeen Beg, Helene Benveniste, Louis Chun, Ramtin Cohanim, Dominick Coleman, Joseph Conrad, Tommy Corrado, Jason Daras, Michelle DiGuglielmo, Vedan Djesevic, Andrew Drollinger, Kathleen Dubrow, Brian Durkin, Ralph Epstein, Christopher J. Gallagher, Xiaojun Guo, Sofie Hussain, Ron Jasiewicz, Anna Kogan, Ursula Landman, Rany Makaryus, Daryn Moller, Tate Montgomery, Matthew Neal, Khoa Nguyen, Marco Palmieri, Shaji Poovathor, Eric Posner, Deborah Richman, Andrew Rozbruch, Misako Sakamaki, Joy Schabel, Bharathi Scott, Peggy Seidman, Shiena Sharma, Vishal Sharma, Ellen Steinberg, Neera Tewari, Jane Yi, Jonida Zeqo, Peter Chung, John Denny, Steven H. Ginsberg, Jeremy Grayson, Jonathan Kraidin, Stephen Lemke, Tejal Patel, Salvatore Zisa, Charles Cowles, Marc Rozner, Shawn Banks, Deborah Brauer, Lebron Cooper, V. Samepathi David, Steve Gayer, Steven Gil, Eric A. Harris, Murlikrishna Kannan, Michael C. Lewis, David A. Lindley, Carlos M. Mijares, Sana Nini, Shafeena Nurani, Sujatha Pentakota, Edgar Pierre, Amy Klash Pulido, Michael Rossi, Miguel Santos, Nancy Setzer-Saade, Adam Sewell, Omair H. Toor, Ashish Udeshi, Patricia Wawroski, Lauren C. Berkow, Dan Berkowitz, Ramola Bhambhani, Kerry K. Blaha, Veronica Busso, Adam J. Carinci, Paul J. Christo, R. Blaine Easley, Ralph J. Fuchs, Samuel M. Galvagno, Nishant Gandhi, Andrew Goins, Robert S. Greenberg, Sayeh Hamzehzadeh, Theresa L. Hartsell, Eugenie Heitmiller, Jeremy M. Huff, Brijen L. Joshi, Sapna Kudchadkar, Jennifer K. Lee, Ira Lehrer, Peter Lin, Justin Lockman, Christine L. Mai, Christina Miller, Nanhi Mitter, Gillian Newman, Daniel Nyhan, Lale Odekon, Rabi Panigrahi, Melissa Pant, Alexander Papangelou, Mark Rossberg, Adam Schiavi, Steven J. Schwartz, Deborah A. Schwengel, Brandon M. Togioka, Tina Tran, Emmett Whitaker, Bradford D. Winters, Christopher Wu, Elena J. Holak, Paul S. Pagel
- Edited by Christopher J. Gallagher, State University of New York, Stony Brook, Michael C. Lewis, University of Miami School of Medicine, Deborah A. Schwengel
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- Book:
- Core Clinical Competencies in Anesthesiology
- Published online:
- 06 July 2010
- Print publication:
- 12 April 2010, pp xi-xii
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