Organon (OGN) and Samsung Bioepis said Tuesday that the US Food and Drug Administration has designated Hadlima high and low concentration autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to AbbVie's (ABBV) Humira.
The FDA previously granted interchangeability designation to Hadlima low-concentration prefilled syringe and single-dose vial in June 2024, the company said.
An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, the company said.
Shares of Organon were 5% higher in recent trading.
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