Samsung Bioepis Co., Ltd. and Regeneron Pharmaceuticals, Inc. have reached a settlement and license agreement regarding the U.S. commercialization of an FDA-approved biosimilar for EYLEA 2 mg (aflibercept).
This decision marks the end of an over 2-year legal battle kick-started by Regeneron filing a patent infringement complaint in late 2023.
Let’s begin with Samsung Bioepis.
As a wholly owned subsidiary of Samsung Biologics, the South Korean biopharmaceutical company specializes in biosimilar development for therapeutic areas such as ophthalmology, immunology, oncology, hematology, endocrinology, and gastroenterology.
And the focus of this settlement agreement?
That would be Samsung’s OPUVIZ 2 mg (aflibercept-yszy) injection, which received FDA approval in May 2024 as one of two first-ever EYLEA biosimilars in the United States for all indications except one.
- See here for our coverage on this therapeutic (pronounced op-u-vis)—and check out its prescribing information (PI).
Next up: this legal situation.
Regeneron filed its complaint months before OPUVIZ’s FDA approval, alleging that Samsung infringed on 37 patents when it submitted an abbreviated Biologics License Application (aBLA) for the biosimilar.
Specifically: The company claimed that Samsung imported 17 shipments of its biosimilar to the United States over a nearly 18-month period (Aug. 29, 2021, to March 28, 2023)
- Why this was an issue: Per Regeneron’s allegations, Samsung’s imported shipments and actions were in violation of patents relating to manufacturing methods, formulations, and the administration of aflibercept.
- See a breakdown of these patent infringements.
Under what federal regulations were these infringements?
That would be the Biologics Price Competition and Innovation Act (BPCIA)—which essentially allows for an expedited biosimilar review process—as well as the BPCIA’s Notice of Commercial Marketing for the biosimilar (see below).
- This notice requires biosimilar applicants to give 180 days’ notice before an intended commercial launch (enabling the sponsor of the name-brand drug to seek injunctive relief in order to protect their patent rights).
Gotcha. Now how did this issue get settled?
We wish we knew the nitty-gritty details. The companies only shared that they signed a settlement and license agreement pertaining to OPUVIZ’s U.S. commercialization—noting that this follows an earlier settlement that cleared the way for the biosimilar’s commercialization across Europe and the rest of the world (ROW).
- Per Samsung: “The other terms of this agreement remain confidential."
Did the company have any comment?
Samsung’s Executive Vice President and Global Head of Commerce Linda Choi MacDonald emphasized the company’s “delight” in resolving “all pending patent-related matters relating to our aflibercept biosimilar across the world.”
- “We are well-positioned to successfully launch our aflibercept biosimilar 2 mg in approved markets, by working closely with healthcare systems, payers, and providers worldwide,” she added.
So when will OPUVIZ be available in the U.S.?
January 2027.
Anything else to keep in mind?
Just one more piece of information: While Samsung scored a victory in securing a commercialization launch date for OPUVIZ, it's actually Harrow, Inc. that is expected to own the exclusive U.S. commercial rights for the biosimilar.
In case you forgot: The companies signed a deal in July 2025 that gave Harrow full responsibility over the U.S. commercialization of OPUVIZ and BYOOVIZ (Samsung’s FDA-approved ranibizumab biosimilar)—but only after Samsung finished transferring the rights from Biogen.
- Why Biogen: The company acquired both biosimilars’ rights in a 2019 partnership with Samsung; however, it has since announced plans to terminate the agreement.
There’s been no update on that process, but with this settlement we can likely expect one over the coming months.
As always, stay tuned!