For biosimilars, the most common failure is an assumption that FDA approval of a biosimilar automatically produces rapid market share conversion when, in practice, brand rebate strategies, formulary positioning decisions, and prescriber inertia all intervene
This is called the ileal brake. The presence of macronutrients in the ileum, the last section of the small intestine, triggers a slowdown of the digestion process and release of appetite-suppressing hormones
Novo Nordisks Response to JAMA Study and Allegations In an emailed statement, Wegovy manufacturer Novo Nordisk countered that there were several limitations of the JAMA study design, which was not a randomized controlled trial, as reported by Reuters
For example, excluding those with uncontrolled hypertension might limit understanding of how the drug affects a significant subset of the obese population, which often experiences hypertension
Post-injection care includes proper disposal of the needle in an FDA-cleared sharps container (or puncture-resistant household container if an FDA-cleared container is unavailable)
Acknowledgements Amgen sponsored this study and was involved in the study design