Bioequivalent generic drugs are substituted for brand-name drugs to lower healthcare costs. The use of generic drugs has escalated in the United States. In 1999, generic drugs comprised 47% of all prescriptions market, and gradually rising to 69% by 2008, saving a whopping $121 billion in 2008 itself. Both the brand-name and generic drugs have the same active ingredient, but the generic drug may differ in the color of the tablet, inert binder, and the formulation process.
The US Foods and Drug Administration relies on bioequivalence studies (bioequivalence clinical trials or BE studies) for the approval of new generic drugs. Bioequivalence studies are based on the pharmacokinetic principles that monitor the rate of absorption (Cmax), the area under plasma concentration (AUC) for the end of the study, and to infinity. FDA has the criteria for the confidence intervals of 90% between the brand-name and generic drugs for these 3 parameters, to be within 80% –125%. Some studies have reported against bioequivalence services for lower efficacy and higher adverse events observed with the generic drugs.
Bioequivalence studies
Bioequivalence is the core component of generic drug testing. However, it is crucial to note that bioequivalence services also perform BE studies for brand-name drugs. These bioequivalence studies are performed in certain situations such as when there is a change in one or more inactive ingredients after a brand-name drug is approved.
Bioequivalence studies act as a surrogate marker for safety and clinical data. For oral drugs, if the active component in the brand-name and generic drug blood concentration is the same, it is accepted that their concentration at the active site and thus their clinical efficacy and safety will also be the same. In the case of other routes of administration, bioequivalence is shown through comparative testing and bioavailability of drugs, to support the clinical efficacy and safety data of the proposed generic drug.
Benefits of bioequivalence clinical trials transparency
As access to bioequivalence clinical trial data is in the public interest, an adequate level of transparency is mandatory. Since 2000, with the creation of ClinicalTrials.gov, clinical trials performed in the United States are required to register with the FDA. Bioequivalence services generally comply with the trial requirements, but with publishing trial results, they may not adhere to the same level of accuracy.
Clinical trial results help strengthen research advancements and optimize data utility and resources. Therefore, transparent, effective, and timely disclosure of bioequivalence clinical trial results will benefit each group of stakeholders.
Patients suffering from critical conditions can review the results of past bioequivalence studies and then can form an informed decision of whether or not to register for potentially lifesaving therapeutic interventions. Clinicians can monitor ongoing bioequivalence clinical trials and stay abreast in their respective fields. They may then be in a better position to share informed clinical advice with their patients.
Researchers can conduct more efficient bioequivalence studies when they have a complete picture of past bioequivalence clinical trials and their results, eventually saving money, time, and other valuable resources. Individuals taking part in bioequivalence clinical trials will gain an in-depth understanding of the trial and will enable them to compare the results from other studies.
Conclusion
Bioequivalence clinical trial transparency is crucial for clinicians, patients, clinical trial participants, researchers, and the public for numerous reasons. Therefore, bioequivalence services should always share sensitive data by following adequate regulatory guidelines.