FDA accepts SB11 BLA for review: A step towards affordable treatment for retinal vascular disorders

The United States Food and Drug Administration (FDA) has recently accepted the biologics license application (BLA) for SB11, a proposed biosimilar referencing Genentech’s Lucentis (ranibizumab). This move marks a significant milestone in the development of affordable treatment options for individuals suffering from retinal vascular disorders, a leading cause of blindness in the United States. The biosimilar SB11 is being developed by Samsung Bioepis in partnership with Biogen, and if approved, it will offer a new therapeutic alternative to patients in need of anti-vascular endothelial growth factor (VEGF) therapies.

Understanding SB11 and Its Role in Retinal Vascular Disorders

SB11 is a biosimilar of Lucentis, which is widely used to treat retinal vascular disorders such as age-related macular degeneration (AMD) and diabetic retinopathy. These conditions, caused by abnormal blood vessel growth in the retina, can lead to severe vision loss and are among the leading causes of blindness in the United States. Ranibizumab, the active ingredient in Lucentis, works by inhibiting VEGF, a protein responsible for the formation of abnormal blood vessels in the eye.

The acceptance of SB11’s BLA by the FDA is a crucial step towards providing patients with an affordable, effective treatment option. Samsung Bioepis, a biopharmaceutical company focused on biosimilars, has been working with Biogen to bring this promising product to market. The collaboration between these two companies aims to make high-quality, cost-effective therapies available to a broader range of patients.

A Partnership for Broader Access and Affordable Treatments

Samsung Bioepis has a longstanding agreement with Biogen for the commercialization of SB11, along with another ophthalmology biosimilar candidate, SB15 (aflibercept). Under this agreement, the two companies are working to bring these treatments to key global markets, including the United States, Canada, Europe, Australia, and Japan.

Hee Kyung Kim, Senior Vice President and Clinical Sciences Division and Regulatory Affairs Team Leader at Samsung Bioepis, emphasized the importance of this filing acceptance, stating that it brings them one step closer to offering affordable treatment options for individuals with retinal vascular disorders. If approved, SB11 could significantly improve the quality of life for millions of Americans suffering from these debilitating conditions. “This FDA filing acceptance for SB11 brings us a step closer to our goal of being able to offer affordable treatment options for people with retinal vascular disorders,” Kim explained.

Biogen, which has a strong track record in the biosimilars market, is equally optimistic about the future of SB11. Ian Henshaw, Biogen’s Senior Vice President and Global Head of Biosimilars, noted that the FDA’s acceptance of SB11 is an important milestone in providing a potential new treatment option for patients with retinal vascular disorders. “Our biosimilar portfolio aims to ensure sustainability of healthcare systems by offering broader patient access to effective and more affordable treatment options,” Henshaw said.

SB11’s Potential Impact on the Biosimilars Market

The acceptance of SB11’s BLA by the FDA is just the latest in a series of positive developments for Samsung Bioepis and Biogen. Last month, SB11’s marketing authorization application (MAA) was also accepted for review by the European Medicines Agency (EMA). This double approval process in both the U.S. and Europe demonstrates the growing confidence in the safety and efficacy of biosimilars as viable alternatives to originator biologics.

SB11 is part of a broader biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen. This portfolio includes three anti-TNF biosimilars—BENEPALI, IMRALDI, and FLIXABI—which are already available in Europe. With the addition of SB11 to this lineup, the companies continue to solidify their position as leaders in the biosimilars space, providing affordable treatment options for a wide range of conditions.

What’s Next for SB11 and Retinal Vascular Disorder Treatment?

If SB11 is approved by the FDA, it will provide a new, cost-effective treatment option for millions of Americans living with retinal vascular disorders. The approval of SB11 would not only benefit patients but could also help alleviate some of the financial strain on healthcare systems, which increasingly rely on affordable biosimilars to ensure the sustainability of treatment access.

Samsung Bioepis and Biogen’s efforts to expand their biosimilar offerings could reshape the landscape of ophthalmic care, particularly in the treatment of retinal vascular disorders. The broader availability of biosimilars like SB11 has the potential to drive down treatment costs and improve patient outcomes on a global scale.

A Step Toward Accessible Healthcare Solutions

The FDA’s acceptance of the biologics license application for SB11 is a promising development in the ongoing efforts to provide affordable, high-quality treatments for retinal vascular disorders. With the potential for approval in both the United States and Europe, SB11 could soon become a critical tool in the fight against vision loss caused by these conditions. The continued partnership between Samsung Bioepis and Biogen underscores the commitment to making biosimilars a cornerstone of modern healthcare.