Generic drugs increase access to care and reduce costs. Due to the high costs of oncology drugs, including chemotherapy agents, hormones, and other drugs, generics have an important role in oncology treatment. However, the approval regulations, availability, and cost vary widely internationally.
In a new study, Tony Yang of the Department of Health Administration and Policy, and colleagues examine the clinical, policy, safety, and regulatory considerations of generic oncology drugs in several countries, including the United States, Canada, the European Union, Japan, China, and India. The study is published in The Lancet Oncology.
"While the International Conference on Harmonization's guidelines set international regulations for generic drugs, quality manufacturing processes are the key to producing safe generic oncology drugs," Yang and authors said. "Generic oncology drugs produced in a developed country are generally safe; however, the narrow therapeutic index of oncology drugs requires improved oversight to ensure bioequivalence."
The authors conclude that, as a result of coordination between the Central Drugs Standard Control Organization and the U.S. Food and Drug Administration, generic oncology drugs used in the United States and other developed countries are usually safe. To improve drug safety, they recommend increased enforcement of regulatory manufacturing and supply chain standards regarding generic oncology drugs. Read the full study.