TY - JOUR
T1 - Generic oncology drugs
T2 - are they all safe?
AU - Yang, Y. Tony
AU - Nagai, Sumimasa
AU - Chen, Brian K.
AU - Qureshi, Zaina P.
AU - Lebby, Akida A.
AU - Kessler, Samuel
AU - Georgantopoulos, Peter
AU - Raisch, Dennis W.
AU - Sartor, Oliver
AU - Hermanson, Terhi
AU - Kane, Robert C.
AU - Hrushesky, William J.
AU - Riente, Joshua J.
AU - Norris, Le Ann B
AU - Bobolts, Laura R.
AU - Armitage, James O.
AU - Bennett, Charles L.
N1 - Funding Information:
This work was funded partly by the National Cancer Institute (R01CA165609), the American Cancer Society (IRG-13-043-01), the South Carolina SmartState Program, and an unrestricted grant from Doris Levkoff Meddin to the South Carolina College of Pharmacy Center for Medication Safety and Efficacy. Funding sources had no role in drafting or approval of the manuscript.
PY - 2016/11/1
Y1 - 2016/11/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84995677646&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84995677646&partnerID=8YFLogxK
U2 - 10.1016/S1470-2045(16)30384-9
DO - 10.1016/S1470-2045(16)30384-9
M3 - Review article
C2 - 27819247
AN - SCOPUS:84995677646
VL - 17
SP - e493-e501
JO - The Lancet Oncology
JF - The Lancet Oncology
SN - 1470-2045
IS - 11
ER -