Definition
Therapeutic Equivalence is an FDA determination that drug products are pharmaceutical equivalents and bioequivalent, meaning they can be substituted for one another with the expectation of the same clinical effect and safety profile.
How Therapeutic Equivalence Works
FDA assigns TE codes to approved drugs in the Orange Book. Pharmacists and healthcare systems use these codes to determine appropriate substitutions.
TE Code Categories
| First Letter | Meaning |
|---|---|
| A | Therapeutically equivalent, substitutable |
| B | Not equivalent or insufficient data |
Common TE Codes
| Code | Meaning |
|---|---|
| AA | No bioequivalence problem expected |
| AB | Bioequivalence demonstrated |
| AN | Aerosol products |
| AT | Topical products |
| BC | Extended-release oral forms |
| BD | Active ingredient and dosage forms differ |
| BN | Nebulizer products |
| BX | Insufficient data |
Why BD Teams Track Therapeutic Equivalence
For business development professionals, TE ratings affect market access:
- Deal Implication: AB rating enables automatic substitution, driving generic uptake
- Due Diligence Focus: Verify TE code and understand any substitution barriers
- Opportunity Signal: Products without AB ratings may have market access challenges