Definition
Bioequivalence (BE) is the demonstration that a generic drug has the same rate and extent of absorption as the brand-name Reference Listed Drug when administered under similar conditions. It’s the scientific basis for generic drug approval.
How Bioequivalence Works
BE studies compare pharmacokinetic parameters between generic and brand products in healthy volunteers, using a crossover design where subjects receive both products.
Key BE Parameters
| Parameter | Meaning | Criteria |
|---|---|---|
| AUC | Area under concentration-time curve (extent) | 90% CI: 80-125% |
| Cmax | Maximum plasma concentration (rate) | 90% CI: 80-125% |
| Tmax | Time to maximum concentration | Not always required |
BE Study Design
Typical bioequivalence studies involve:
- 24-48 healthy adult volunteers
- Single-dose crossover design
- Fasting or fed conditions (or both)
- Blood sampling over 72+ hours
- Bioanalytical method validation
Why BD Teams Track Bioequivalence
For business development professionals, BE data is fundamental for generics:
- Deal Implication: Successful BE study is critical milestone for ANDA programs
- Due Diligence Focus: Review BE study design and whether FDA has accepted approach
- Opportunity Signal: Complex products with difficult BE challenges may seek partners