title: Regulatory and clinical considerations for biosimilar oncology drugs.
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.
authors.affiliation: 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.
authors.forename: Charles L
authors.initials: CL
authors.lastname: Bennett
authors.affiliation: 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.
authors.forename: Brian
authors.initials: B
authors.lastname: Chen
authors.affiliation: Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Terhi
authors.initials: T
authors.lastname: Hermanson
authors.affiliation: 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.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Wyatt
authors.affiliation: 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.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Schulz
authors.affiliation: 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.
authors.forename: Peter
authors.initials: P
authors.lastname: Georgantopoulos
authors.affiliation: 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.
authors.forename: Samuel
authors.initials: S
authors.lastname: Kessler
authors.affiliation: University of New Mexico, College of Pharmacy, Albuquerque, NM, USA.
authors.forename: Dennis W
authors.initials: DW
authors.lastname: Raisch
authors.affiliation: 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.
authors.forename: Zaina P
authors.initials: ZP
authors.lastname: Qureshi
authors.affiliation: 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.
authors.forename: Z Kevin
authors.initials: ZK
authors.lastname: Lu
authors.affiliation: 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.
authors.forename: Bryan L
authors.initials: BL
authors.lastname: Love
authors.affiliation: 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.
authors.forename: Virginia
authors.initials: V
authors.lastname: Noxon
authors.affiliation: Oncology Analytics Inc, Plantation, FL, USA; Nova Southeastern University College of Pharmacy, Fort Lauderdale, FL, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Bobolts
authors.affiliation: Oncology Analytics Inc, Plantation, FL, USA; University of South Florida College of Pharmacy, Tampa, FL, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Armitage
authors.affiliation: 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.
authors.forename: John
authors.initials: J
authors.lastname: Bian
authors.affiliation: 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.
authors.forename: Paul
authors.initials: P
authors.lastname: Ray
authors.affiliation: 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.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Ablin
authors.affiliation: 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.
authors.forename: William J
authors.initials: WJ
authors.lastname: Hrushesky
authors.affiliation: King's College Hospital, London, UK.
authors.forename: Iain C
authors.initials: IC
authors.lastname: Macdougall
authors.affiliation: Tulane University School of Medicine, New Orleans, LA, USA.
authors.forename: Oliver
authors.initials: O
authors.lastname: Sartor
authors.affiliation: University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: James O
authors.initials: JO
authors.lastname: Armitage
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000592:standards* / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals