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.