Generic oncology drugs: are they all safe?
Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel). We also review regulatory reports from Japan and the USA, countries with the largest pharmaceutical expenditures. Empirical studies did not identify safety concerns in the USA, Canada, the EU, and Japan, where regulations and enforcement are strong. Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist. Regulatory agencies should collaboratively develop procedures to monitor the production, shipment, storage, and post-marketing safety of generic oncology drugs. Regulatory agencies for each country should also aim towards identical definitions of bioequivalence, the cornerstone of regulatory approval.
College of Health and Human Services, George Mason University, Fairfax, VA, USA.
Y Tony
YT
Yang
Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Sumimasa
S
Nagai
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; William Jennings Bryan Dorn Veterans Affairs Medical Center, Columbia, SC, USA; Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.
Brian K
BK
Chen
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; William Jennings Bryan Dorn Veterans Affairs Medical Center, Columbia, SC, USA; Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.
Zaina P
ZP
Qureshi
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; William Jennings Bryan Dorn Veterans Affairs Medical Center, Columbia, SC, USA.
Akida A
AA
Lebby
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA.
Samuel
S
Kessler
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; William Jennings Bryan Dorn Veterans Affairs Medical Center, Columbia, SC, USA; Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.
Peter
P
Georgantopoulos
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of New Mexico College of Pharmacy, Albuquerque, NM, USA.
Dennis W
DW
Raisch
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; Tulane University School of Medicine, New Orleans, LA, USA.
Oliver
O
Sartor
Helsinki University Hospital, Helsinki, Finland.
Terhi
T
Hermanson
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; Oncology Center, Venice, FL, USA.
Robert C
RC
Kane
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health Cancer Epidemiology, Columbia, SC, USA; Medical University of South Carolina School of Medicine and Cancer Center, Charleston, SC, USA.
William J
WJ
Hrushesky
William Jennings Bryan Dorn Veterans Affairs Medical Center, Columbia, SC, USA.
Joshua J
JJ
Riente
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; William Jennings Bryan Dorn Veterans Affairs Medical Center, Columbia, SC, USA.
LeAnn B
LB
Norris
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; Oncology Analytics Corporation, Plantation, FL, USA; Nova Southeastern University, College of Pharmacy, FL, USA.
Laura R
LR
Bobolts
Division of Hematology and Oncology, Department of Medicine, University of Nebraska School of Medicine, Omaha, NE, USA.
James O
JO
Armitage
Southern Network on Adverse Reactions (SONAR), South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, SC, USA; William Jennings Bryan Dorn Veterans Affairs Medical Center, Columbia, SC, USA; Arnold School of Public Health, University of South Carolina, Columbia, SC, USA; Medical University of South Carolina School of Medicine and Cancer Center, Charleston, SC, USA. Electronic address: bennettc@sccp.sc.edu.
Charles L
CL
Bennett
D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000633:toxicity; D004335:Drug and Narcotic Control; D016568:Drugs, Generic / Q000009:adverse effects* / Q000633:toxicity; D006801:Humans; D013810:Therapeutic Equivalency
D000970:Antineoplastic Agents; D016568:Drugs, Generic