FDA's First Approved Lucentis Biosimilar
Portfolio Diversification Accelerates with Expansion to 6 Products...

Samsung Bioepis Biowebiz.

Samsung Bioepis Biowebiz.

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[Asia Economy Reporter Lee Gwan-joo] Samsung Bioepis announced on the 3rd that it has launched the ophthalmic disease treatment drug 'Byooviz' (SB11, generic name ranibizumab) in the U.S. market.


Byooviz is a biosimilar product of 'Lucentis,' an ophthalmic disease treatment drug for wet age-related macular degeneration and diabetic macular edema, sold by Roche and Novartis. Lucentis recorded annual sales of 4.4 trillion KRW last year, with approximately 1.8 trillion KRW (41%) of that coming from the U.S. market.


Byooviz was launched in the U.S. market at a wholesale acquisition cost (WAC) of $1,130, about 40% cheaper than the original drug based on a single-use dose (0.5 mg), and local marketing and sales activities have started this month by partner Biogen.


Samsung Bioepis obtained the first approval to sell the Lucentis biosimilar in Europe and the U.S. in August and September last year, respectively, and in Korea (under the brand name Amelibu) in May this year.


Go Han-seung, CEO of Samsung Bioepis, said, “We are pleased to introduce our first ophthalmic disease treatment drug to the world's largest pharmaceutical market, the U.S. We will strive to provide optimal treatment benefits to patients and continue to expand our product portfolio into various fields.”


Samsung Bioepis exterior.

Samsung Bioepis exterior.

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Samsung Bioepis, celebrating its 10th anniversary this year, has a total of 10 products and pipelines. With the launch of Byooviz, the number of products on sale has increased to six, including autoimmune disease treatments (SB2, SB4, SB5) and anticancer drugs (SB3, SB8), diversifying its business areas and product portfolio.



Additionally, as follow-up pipelines, it is developing four biosimilars of blockbuster drugs nearing patent expiration. The rare blood disease treatment SB12 (biosimilar of 'Soliris') and the ophthalmic disease treatment SB15 (biosimilar of 'Eylea') have completed Phase 3 clinical trials, while the metabolic disease treatment SB16 (biosimilar of 'Prolia') and autoimmune disease treatment SB17 (biosimilar of 'Stelara') are currently undergoing Phase 3 clinical trials.


This content was produced with the assistance of AI translation services.

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