[Alpha Biz= Paul Lee] Samsung Bioepis announced on July 18 that it has signed a commercialization partnership with U.S.-based pharmaceutical company Harrow to expand sales of its ophthalmology biosimilars in the U.S. market, valued at approximately KRW 9 trillion (USD 6.5 billion).
Harrow, a NASDAQ-listed company, specializes in ophthalmic therapies and maintains a strong sales network with U.S. eye hospitals. Under this new agreement, Harrow will take over the U.S. commercialization of two of Samsung Bioepis’ ophthalmology biosimilars: Byooviz and Opuviz, replacing Biogen as the previous distributor by the end of 2024.
Byooviz is a biosimilar referencing Lucentis, indicated for wet age-related macular degeneration (wAMD) and macular edema following retinal vein occlusion. It was the first Lucentis biosimilar to receive U.S. FDA approval in September 2021 and entered the U.S. market in June 2022.
Opuviz, a biosimilar to Eylea, is indicated for wAMD and diabetic macular edema (DME). It received FDA approval in May 2024. In the U.S., the biosimilar markets for Lucentis and Eylea are estimated at approximately KRW 2.6 trillion (USD 1.9 billion) and KRW 8.8 trillion (USD 6.5 billion), respectively.
Samsung Bioepis continues to strengthen its position in the world’s largest biosimilar market, building on its successful track record in Europe, where it holds leading market shares in biosimilars referencing Stelara and Enbrel for autoimmune diseases. In the U.S., the company has already launched biosimilars referencing Humira, Remicade, Herceptin, and Soliris.
Alphabiz Reporter Paul Lee(hoondork1977@alphabiz.co.kr)