10:51 AM EDT, 05/27/2025 (MT Newswires) -- 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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