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Biowaiver monograph for immediate-release solid oral dosage forms: Empagliflozin
Reiji Negoya1, Mayuki Tsueoka1, Xichen Sun1
1Faculty of Pharmaceutical Sciences, Tokyo University of Science, Tokyo, Japan.
Journal of Pharmaceutical Sciences
|October 11, 2025
Summary
This study assesses the Biopharmaceutics Classification System (BCS)-based biowaiver for empagliflozin, an SGLT2 inhibitor for Type 2 diabetes. Empagliflozin is suitable for a biowaiver, simplifying generic drug approvals.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Regulatory Science
Background:
- Empagliflozin is a key sodium glucose co-transporter (SGLT2) inhibitor for managing Type 2 diabetes mellitus.
- Generic drug development requires efficient pathways for market entry.
Purpose of the Study:
- To evaluate the eligibility of empagliflozin for a Biopharmaceutics Classification System (BCS)-based biowaiver.
- To determine if clinical studies can be waived for generic empagliflozin formulations.
Main Methods:
- Review of published data on empagliflozin's solubility and membrane permeability.
- Assessment of formulation performance, specifically dissolution profiles.
- Comparison with innovator product (Jardiance) characteristics.
Main Results:
- Empagliflozin exhibits high solubility but low membrane permeability, classifying it as a BCS Class III drug.
- Rapid dissolution (≥85% in 15 minutes) is achievable for immediate-release formulations.
- Formulations similar to the innovator product meeting dissolution criteria are eligible for biowaiver.
Conclusions:
- Empagliflozin meets the criteria for a BCS-based biowaiver.
- Applying this biowaiver can expedite the approval of generic empagliflozin products.
- This facilitates global access to essential diabetes medication.
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