Osimertinib is marketed by more than one company under different brand names. It is therefore essential to distinguish the originator/reference product from later generic or alternative branded products.
AstraZeneca and Tagrisso
Tagrisso is the established reference product. DailyMed identifies AstraZeneca Pharmaceuticals LP as the U.S. packager. EMA’s Tagrisso record identifies the medicine as osimertinib and records its EU authorization.
Beacon Pharmaceuticals and Tagrix
Beacon Pharmaceuticals’ official product information identifies Tagrix as osimertinib 80 mg and describes its tablet formulation.
Incepta Pharmaceuticals and Osicent
Incepta’s official product information identifies Osicent 80 as containing osimertinib mesylate equivalent to 80 mg osimertinib.
Everest Pharmaceuticals and Osimert
Everest’s official product catalogue identifies Osimert as osimertinib 80 mg. Everest also announced the export launch of Osimert 80 mg in 2018.
Manufacturer does not mean originator
A manufacturer of a generic product is not necessarily the company that originally developed the active ingredient or reference product.
These roles may include:
- Originator/developer
- Reference-product manufacturer
- Generic manufacturer
- Brand owner
- Marketing authorization holder
- Distributor
- Supplier
They should be identified separately when documentation supports doing so.