Biogen Gets Positive Opinion in Europe for Eye Drug
June 25 2021 - 8:45AM
Dow Jones News
By Matt Grossman
Biogen Inc. and Samsung Bioepis Co. Ltd. have received a
positive opinion from Europe's Committee for Medicinal Products for
Human Use for Byooviz, a biosimilar candidate to treat eye
conditions, the companies said Friday.
Byooviz references an existing drug called Lucentis, which is
used to treat retinal vascular disorders, which can cause
blindness. Byooviz was developed by Samsung Bioepis and would be
commercialized by Biogen if the drug receives final European
Commission approval.
The committee's positive opinion was based on a Phase 3 study in
which the drug demonstrated equivalence in efficacy for both
primary endpoints.
Write to Matt Grossman at matt.grossman@wsj.com
(END) Dow Jones Newswires
June 25, 2021 08:30 ET (12:30 GMT)
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