Drug Approval | September 21, 2021
U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
Results from year two of the pivotal Phase 3 KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one
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