When developing a generic drug for global markets, one critical decision can save months of development time and significant costs — choosing between a BCS-based biowaiver and an in vivo bioequivalence (BE) study.
Comparison to help guide your strategy:
BCS-Based Biowaiver
- Applicable for BCS Class I/III drugs
- Requires solubility, permeability, and dissolution data
- Saves up to 90% of development cost
- Reduces development time by 6–9 months
- No need for clinical studies in human subjects
In Vivo BE Study
- Mandatory for BCS Class II/IV or modified-release formulations
- Involves PK studies in healthy volunteers
- Higher risk, cost, and timeline
- Universally accepted by regulatory agencies
Regulatory Trend
- USFDA, EMA, and WHO support BCS-based biowaivers when scientifically justified.
- As biowaiver acceptance grows globally, companies can use this route to accelerate market entry and maximize return on investment.
- Early BCS classification and robust in vitro dissolution data can pave the way for a faster, more efficient ANDA submission.
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Resource Person: Vijay Agrawal