The edition · Clinical Pharmacology
Genes versus drinking history for topiramate, a generic DPP-4, and biosimilar switching
A machine-learning study weighs pharmacogenomics against drinking history for topiramate in alcohol use disorder, a generic teneligliptin meets bioequivalence, the FDA logs a tirzepatide supplement, and expert guidance supports anti-VEGF biosimilars in stable patients.
The edition in brief
Five items for clinical pharmacologists and the prescribers who consult them. A machine-learning analysis of a topiramate trial in alcohol use disorder found that pre-treatment drinking measures, not genetics, were the strongest predictors of response, though a polygenic score for time-to-relapse added modestly (model R-squared 0.30); pharmacogenomics is promising but not yet ready to select patients. A bioequivalence study showed a generic teneligliptin matched the reference DPP-4 inhibitor within the standard 80 to 125% bounds, fasting and fed, supporting substitution for cost. The FDA approved a supplement to the tirzepatide (Zepbound) application, an administrative record whose scope is not specified here, so prescribers should check the updated label rather than assume a new indication. A pearl covers when generic or biosimilar substitution needs extra care, including narrow-therapeutic-index drugs. The practice-changer is expert guidance that anti-VEGF biosimilars are clinically equivalent to reference ranibizumab and aflibercept and can be initiated, or switched into for stable patients under monitoring, with caution about repeated switching between products.
For topiramate in alcohol use disorder, drinking history still beats genes
Use a careful drinking history, not a genetic test, to judge who may respond to topiramate for alcohol use disorder; pharmacogenomic scores are a promising add-on, not yet a selection tool.
A generic teneligliptin matches the reference product
Substitute this generic teneligliptin for the branded product with confidence where cost matters; it met standard bioequivalence criteria fasting and fed.
FDA logs a supplement to the tirzepatide application
Do not read this bare supplement approval as a new tirzepatide indication; check the current label for the actual change before altering prescribing.
When generic or biosimilar substitution needs extra care
Treat most substitutions as routine, but keep narrow-therapeutic-index drugs on a consistent product with monitoring, and document the exact biologic given.
Anti-VEGF biosimilars can be used, and switched into, with confidence
Use anti-VEGF biosimilars as a default to widen access, including switching clinically stable patients under monitoring, while avoiding repeated back-and-forth switching and keeping traceability.
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