Skip to content
Buy This GLP
← Research
Safety

Compounded copies: tested by the company that makes the original

Copies of semaglutide and liraglutide carried different impurities and looked more immunogenic in the lab. Every author works for the originator's manufacturer.

Carla Medina7 min read
What this study measured, and what it did notamino acid deletions and additionsfoundunidentified impuritiesfoundchanges in strength after lightfoundreduced physical stabilityfoundan immune reaction in a patientnot measuredConducted entirely by employees of the originator's manufacturer.

Two things about this paper are true at once and the page states both before anything else. The measurements are real, specific and the sort nobody outside a manufacturer can easily make. And the manufacturer is the one whose products the copies compete with — which is a fact about provenance, not a verdict, and the same one this desk applies to any favorable comparison.

Who did the work

The authors are employees and shareholders of Novo Nordisk, which makes both of the originator products used as the reference. [1] One further author was an employee at the time of the study and remains a shareholder.

That does not make the chemistry wrong. A company holds the reference material, the validated assays and the manufacturing knowledge for its own molecule, and it is often the only party able to run this comparison at all. It does mean the result arrives from an interested party and should be weighted accordingly, in the same way a trial funded by a copy’s maker would be.

What they found

Follow-on drug substance, follow-on products and compounded products all showed impurity profiles distinct from the originators: amino acid deletions and additions, and impurities the analysis could not identify.

Exposed to light, compounded semaglutide differed significantly from the originator on strength, total impurities and high-molecular-weight protein content. The liraglutide follow-ons had reduced physical stability.

The light result is the practical one

Originator products move through a cold chain designed and validated by their manufacturer. A compounded vial is shipped to a residential address and stored in somebody’s kitchen.

A product whose strength and impurity content shift measurably under light exposure is a product whose handling matters more than the label suggests — and handling is the part of the supply chain a buyer controls and nobody audits, alongside what happens between the vial and the syringe.

What a buyer should take

That “compounded semaglutide” and “semaglutide” are not established to be the same substance at the level of impurities, and that nobody has shown the difference makes people ill.

Both halves matter. A page that printed only the first would be doing an interested party’s marketing; a page that printed only the second would be telling a reader an unknown is a reassurance. Where a product is dispensed from — and under which compounding rules — remains the most useful thing a buyer can actually check.

Frequently asked

Are compounded GLP-1 products dangerous?
This study did not test that. It found different impurity profiles and greater immunogenic potential in a laboratory assay, with no patients involved and no clinical outcome measured.
Who ran the study?
Employees and shareholders of the company that makes both originator products used as the comparison. That does not make the chemistry wrong, and it is a fact worth weighting.
What does 'immunogenic potential' mean?
Impurities were used to stimulate immune cells grown from healthy donors, and more and different peptides were displayed than with the originators. It predicts a reaction rather than observing one.
What is the most practical finding?
Compounded semaglutide changed measurably in strength and impurity content after light exposure — and compounded vials are shipped to homes rather than handled in a validated cold chain.

Sources

  1. [1] Kopp KL, et al. (2026). Impurities and Potential Immunogenicity Associated With Follow-on and Compounded Glucagon-like Peptide-1 Receptor Agonists Pharmaceutical Research. PMID 42533250

More in Safety