Samsung Bioepis launches first FDA-approved ophthalmology biosim Byooviz in U.S.

2022.06.07 13:39:50 | 2022.06.07 13:40:16

[Source: Samsung Bioepis]이미지 확대

[Source: Samsung Bioepis]

Samsung Bioepis has made a foray into the U.S. eye disease market with the launch of Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis, expanding its autoimmune disease and oncology focused product portfolio.

Byooviz will be commercially available through major distributors across the U.S. on July 1, 2022, the company said on Sunday.

Byooviz, which is the first FDA-approved biosimilar, is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

The company expects its biosimilar would penetrate the market rapidly given its list price will be $1,130 per single use vial to administer 0.5mg via intravitreal injection, 40 percent lower than the current list price of Lucentis.

Lucentis sales totaled more than $3.5 billion worldwide last year with 41 percent or $1.43 billion coming from the U.S. market.

By Kim Si-gyun and Minu Kim

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