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FDA recognized Hadlima as an interchangeable biosimilar for Humira, supporting Organon's biosimilars pipeline.

1 report, 1 independent Updated Sep 1

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What happened

Some supportReported by 1 outlet

Who's involved

What this event is mainly about

FDA HUMIRA Organon & Co.

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The entities involved

FDA
- Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
- A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
HUMIRA
Czech company
- AbbVie's product portfolio was bolstered by the acquisition of Allergan, while Humira sales faced erosion due to patent loss and biosimilar competition.Sun 13:48
- Lost patent protection for Humira in the US on August 20, 2025.Thu 06:13
Organon & Co.
pharmaceutical company
- Organon & Co. and Spero Therapeutics Inc., two healthcare companies, are currently competing for investment opportunities.Wed 11:24

Coverage

Newest first; wire copies grouped

Sep 1Simply Wall St.How Investors Are Reacting To Organon (OGN) Lifting 2025 Guidance and CEO Share Purchase Organon recently advanced its VTAMA cream and expanded its women’s health portfolio, prompting an increase in