Organon wins US approval to widen use of arthritis biosimilar drug

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.

(Reporting by Sahil Pandey in Bengaluru; Editing by Sahal Muhammed)

Copyright Reuters or USA Today Network via Reuters Connect

This story was originally published June 10, 2026 at 5:44 AM.