Generic and branded drugs for the treatment of people living with HIV/AIDS.
HIV/AIDS care has benefited tremendously from the availability of antiretroviral (ARV) drugs, both branded and generic. Drug discovery and innovation is the result of direct investment in the development of branded medications, a crucial process for future improvements in care. However, the cost of branded medications is too high for resource-limited countries, where most persons with HIV/AIDS live. Generic drugs dramatically lower the cost of care; however, their safety and efficacy must be ensured and maintained. Proven bioavailability and bioequivalence, in addition to satisfactory manufacturing, distribution, and administration, are keys to successfully implementing the use of qualified generic ARVs. Agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMEA), and the World Health Organization (WHO), continue to strengthen the surveillance process through which qualified generic and branded drugs are provided worldwide. Generic drugs have the potential to cause harm if rigorous standards for their use are not followed, but those that are qualified offer great promise in the treatment of HIV/AIDS.
Bartlett
John A
JA
Division of Infectious Disease and International Health, Duke University Medical Center, Durham, North Carolina 27710, USA. jab5@acpub.duke.edu
Muro
Eva P
EP
D044966:Anti-Retroviral Agents / Q000191:economics* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D016568:Drugs, Generic / Q000191:economics* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence; D013810:Therapeutic Equivalency
D044966:Anti-Retroviral Agents; D016568:Drugs, Generic