Regulatory and clinical considerations for biosimilar oncology drugs

Charles L Bennett¹, Brian Chen², Terhi Hermanson³, Michael D Wyatt⁴, Richard M Schulz⁴, Peter Georgantopoulos⁵, Samuel Kessler⁴, Dennis W Raisch⁶, Zaina P Qureshi², Z Kevin Lu⁷, Bryan L Love⁸, Virginia Noxon⁴, Laura Bobolts⁹, Melissa Armitage¹⁰, John Bian⁴, Paul Ray¹¹, Richard J Ablin¹², William J Hrushesky¹³, Iain C Macdougall¹⁴, Oliver Sartor¹⁵, James O Armitage¹⁶

Affiliations

¹ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bennettc@sccp.sc.edu.
² The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA.
³ Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland.
⁴ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA.
⁵ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA.
⁶ University of New Mexico, College of Pharmacy, Albuquerque, NM, USA.
⁷ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA.
⁸ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA.
⁹ Oncology Analytics Inc, Plantation, FL, USA; Nova Southeastern University College of Pharmacy, Fort Lauderdale, FL, USA.
¹⁰ Oncology Analytics Inc, Plantation, FL, USA; University of South Florida College of Pharmacy, Tampa, FL, USA.
¹¹ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; Midwestern University, Downers Grove, IL, USA.
¹² The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of Arizona College of Medicine, Tucson, AZ, USA.
¹³ University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA; Oncology Analytics Inc, Plantation, FL, USA.
¹⁴ King's College Hospital, London, UK.
¹⁵ Tulane University School of Medicine, New Orleans, LA, USA.
¹⁶ University of Nebraska Medical Center, Omaha, NE, USA.

PMID: 25456378
PMCID: PMC4404762
DOI: 10.1016/S1470-2045(14)70365-1

Review

Regulatory and clinical considerations for biosimilar oncology drugs

Charles L Bennett et al. Lancet Oncol. 2014 Dec.

. 2014 Dec;15(13):e594-e605.

doi: 10.1016/S1470-2045(14)70365-1. Epub 2014 Nov 24.

Authors

Affiliations

¹ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bennettc@sccp.sc.edu.
² The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA.
³ Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland.
⁴ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA.
⁵ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA.
⁶ University of New Mexico, College of Pharmacy, Albuquerque, NM, USA.
⁷ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA.
⁸ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA.
⁹ Oncology Analytics Inc, Plantation, FL, USA; Nova Southeastern University College of Pharmacy, Fort Lauderdale, FL, USA.
¹⁰ Oncology Analytics Inc, Plantation, FL, USA; University of South Florida College of Pharmacy, Tampa, FL, USA.
¹¹ The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; Midwestern University, Downers Grove, IL, USA.
¹² The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of Arizona College of Medicine, Tucson, AZ, USA.
¹³ University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA; Oncology Analytics Inc, Plantation, FL, USA.
¹⁴ King's College Hospital, London, UK.
¹⁵ Tulane University School of Medicine, New Orleans, LA, USA.
¹⁶ University of Nebraska Medical Center, Omaha, NE, USA.

PMID: 25456378
PMCID: PMC4404762
DOI: 10.1016/S1470-2045(14)70365-1

Abstract

Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.

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Comment in

Japanese regulatory authority's perspective on biosimilars.
Nagai S, Yanagihara R, Kishioka Y. Nagai S, et al. Lancet Oncol. 2015 Mar;16(3):e101. doi: 10.1016/S1470-2045(14)71220-3. Lancet Oncol. 2015. PMID: 25752552 No abstract available.
Japanese regulatory authority's perspective on biosimilars - authors' reply.
Bennett CL, Chen B, Hermanson T, Georgantopoulos P, Sartor OA. Bennett CL, et al. Lancet Oncol. 2015 Mar;16(3):e102. doi: 10.1016/S1470-2045(15)70047-1. Lancet Oncol. 2015. PMID: 25752553 Free PMC article. No abstract available.

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Regulatory and clinical considerations for biosimilar oncology drugs

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Regulatory and clinical considerations for biosimilar oncology drugs

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