Samsung BIoepis announced that it has relaunched Byooviz US marketing efforts with Harrow, the ophthalmology product commercialization partner it signed last July; Lupin receives FDA approval for its own ranibizumab biosimilar.
On July 1, Samsung Bioepis announced that the pause in marketing for its ranibizumab biosimilar Byooviz has come to a close, with the relaunch of the product with its new marketing partner Harrow.
Approved in September 2021 as the first ranibizumab biosimilar, Byooviz marketing efforts had dropped off since December 2025, when Biogen’s commercialization rights to the product were reverted back to Samsung Bioepis. Biogen had been responsible for commercialization of the product in the US.
“Today marks an exciting new chapter for Byooviz in the US. As the first FDA-approved biosimilar to Lucentis, Byooviz has already demonstrated its value in expanding access to critical retinal disease treatments. With Harrow now leading commercialization efforts, we are reigniting our commitment to ensuring patients and retina specialists across America to have access to this quality-proven, safe and effective biosimilar option,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, Samsung Bioepis. “We believe this relaunch will ultimately help more patients with critical ophthalmic diseases to receive the vision-saving treatments they need.”
A Difficult Road for Ranibizumab Biosimilars
Byooviz failed to gain traction for its intended market—patients with wet age-related macular degeneration, macular edema following retinal vein occlusion, or myopic choroidal neo vascularization. It reached its peak marketshare of about 8% in 2024, trailing its biosimilar competitor (Cimerli, then at 34%).
Overall, the biosimilar market for ranibizumab has a long climb back into the utilization picture: Byooviz has only 2% share, according to the latest Samsung Bioepis Biosimilar Market Report; Cimerli’s share dropped to zero, after a pause in marketing by Sandoz, caused by falling average sales prices. According to Q2 2026 report, ASP prices ranged from $320 to $398 for a 0.5-mg injection. However, the CMS July 2026 ASP file indicate a range of $255.45 for the reference product Lucentis to $1,204.85 for Byooviz for the 0.5-mg injection.
It is likely that the aflibercept market represents a greater opportunity for Samsung, Harrow, and the rest of the biosimilar industry relative to the ranibizumab category. Not only has ranibizumab had to battle for share against agents like aflibercept and newer technologies, but the use of off-label, compounded bevacizumab is also a constant threat.
Harrow will also market Samsung’s aflibercept biosimilar, Opuviz, when it is launched later this year.
Lupin Joins the Ranibizumab Fray
In related news, Lupin had announced that its own ranibizumab biosimilar has been approved in early June. This product, dubbed Ranluspec (ranibizumab-hkdz), will be available both as a vial and prefilled syringe.
In the company’s press release, Dr. Cyrus Karkaria, President – Biotechnology, Lupin, stated, “The US FDA approval of our biosimilar ranibizumab underscores our scientific expertise in biologics development and manufacturing, and reinforces our commitment to expanding access to advanced, affordable therapies for patients worldwide.”
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.
