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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