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Organon wins US approval to widen use of arthritis biosimilar drug
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Organon wins US approval to widen use of arthritis biosimilar drug
Jun 10, 2026 6:09 AM

June 10 (Reuters) - Organon said on Wednesday the

U.S. Food and Drug Administration has approved the expanded use

of its arthritis drug, a biosimilar to Roche's Actemra,

to treat a life-threatening immune reaction in some cancer

patients and COVID-19 in patients needing breathing support.

Here are a few details:

* The FDA approval expands use of its biosimilar, Tofidence,

to treat severe or life-threatening cytokine release syndrome in

some cancer patients and for COVID-19 patients who are receiving

oxygen or breathing support and systemic corticosteroids.

* In cytokine release syndrome, the body releases excessive

inflammatory proteins.

* Organon said Tofidence can now be used in adults and

children aged two years and older for both conditions.

* The drug is a biosimilar, meaning it is a close copy of

Roche's Actemra used to treat types of arthritis, for which

Tofidence is also approved.

* "In the U.S., biosimilar adoption may help reduce the

affordability burden of high-cost brand biologics on the health

care system," said Jon Martin, U.S. commercial lead, biosimilars

and established brands, at Organon.

* Organon said Tofidence was approved by the FDA in 2023 as

the first U.S. biosimilar to Actemra.

* In April, India's Sun Pharmaceutical Industries

said it will buy Organon in an all-cash deal valued at about

$11.75 billion including debt, in the largest overseas

acquisition by an Indian pharmaceutical company.

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