Biogen's Tofidence Intravenous Formulation Gets FDA Approval
29 Septembre 2023 - 10:49PM
Dow Jones News
By Denny Jacob
Biogen's tofidence intravenous formulation was approved by the
U.S. Food and Drug Administration, the biopharmaceutical company
said Friday.
The company said the tofidence intravenous formulation was
approved for the treatment of moderately to severely active
rheumatoid arthritis, polyarticular juvenile idiopathic arthritis
and systemic juvenile idiopathic arthritis.
Tofidence intravenous formulation is a biosimilar monoclonal
antibody referencing actemra. Biosimilars are products that have
been demonstrated to have equivalent efficacy and comparable safety
as its approved reference product.
"With the increasing numbers of approved biosimilars, we expect
increased savings and sustainability for healthcare systems and an
increase in physician choice and patient access to biologics," said
Ian Henshaw, global head of biosimilars at Biogen.
Biogen and Bio-Thera entered into a commercialziaiton and
license agreement for tofidence in April 2021. Developed by
Bio-Thera, tofidence will be commercialized by Biogen in the
U.S.
Under their agreement, Biogen has exclusive regulatory,
manufacturing and commercial rights to tofidence in all countries
excluding China. It is currently evaluating the potential launch
timeline for tofidence in the U.S.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
September 29, 2023 16:34 ET (20:34 GMT)
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