GENE ONLINE|News &
Opinion
Blog

2021-09-22| Asia-Pacific

FDA Approves Samsung Bioepis and Biogen’s Lucentis Biosimilar

by Kathy Huang
Share To

On September 20th , Byooviz, a Lucentis biosimilar developed by Samsung Bioepis and Biogen, won FDA approval, making it the first ophthalmology biosimilar to be approved by the FDA. 

Byooviz (ranibizumab-nuna) references Roche’s blockbuster drug Lucentis. The alternative option to Lucentis is approved as treatment for three eye disorders: the “wet” form of neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

 

Roche’s Blockbuster Drug Lucentis

Lucentis is an antibody drug that blocks vascular endothelial growth factor (VEGF), a protein promoting abnormal growth of blood vessels in several eye diseases. By monthly injection, Lucentis blocks the abnormal pathway in the eyes, allowing them to function normally.

In 2020, Roche’s Lucentis generated more than $1.6 billion in sales, down from $1.8 billion in 2019. The decline will become more pronounced as rivals pop out from the biosimilars market.

 

Two Companies’ Ophthalmology Biosimilar Collaboration 

The FDA approval is based on a Phase 3 efficacy and safety study published this January, which enrolled 705 participants over 52 weeks. The results showed that Byooviz demonstrated equivalent safety and efficacy to Roche’s Lucentis, while the immunogenicity was also comparable. Byooviz may launch in the U.S. market starting from June 2022.

The collaboration between Samsung Bioepis and Biogen can be traced back to November 2019, when two companies partnered to develop two ophthalmology biosimilar candidates. Besides Byooviz, another biosimilar drug SB15 references Regeneron Pharmaceuticals’ Eylea. Samsung Bioepis launched a Phase 3 clinical trial for SB15 in late June.

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
Biogen Concludes $900 Million Settlement Before Posting Positive Data From Alzheimer’s Trial
2022-09-28
Fennec’s PEDMARK Finally Gains FDA Approval to Treat Chemo-Induced Hearing Loss
2022-09-22
BMS’s Once-Daily Plaque Psoriasis Treatment, Sotyktu, Gains FDA Approval to Rival Otezla
2022-09-12
LATEST
AstraZeneca Welcomes Neurofibromatosis And Asthma Treatment Approvals in Japan
2022-09-28
Biogen Concludes $900 Million Settlement Before Posting Positive Data From Alzheimer’s Trial
2022-09-28
Arsenal Biosciences Announced Another $70 million Collaboration, This Time With Genentech
2022-09-27
Sciwind Biosciences And SynerK Join Forces To Develop siRNA Therapeutics
2022-09-27
Acticor Enrolls First Patient in Phase 2/3 Stroke Treatment Study
2022-09-27
Daiichi Sankyo Wins Approval For Cancer Treatment in Japan
2022-09-26
Seagen Strikes Potential $650 million Deal with LAVA Therapeutics for Cancer Treatment
2022-09-26
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!