Samsung Bioepis and Biogen Announce FDA Acceptance of BLA for SB11, a Ranibizumab Biosimilar Referencing Lucentis®

November 19, 2020 News /Bio ValleyBIOON/ -- Biogen and Samsung Bioepis recently jointly announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for SB11, a biosimilar with the reference product beingNovartisand Roche’s ophthalmic biologic brand, Lucentis (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy used to treat retinal vascular diseases, which are the leading cause of blindness in the United States.

Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial growth factor A (VEGF-A), whose levels are elevated in neovascular age-related macular degeneration (nAMD) and various other ophthalmic diseases. Lucentis was launched in 2006 and developed collaboratively by Genentech, a member of the Roche Group, and Novartis. Roche holds the commercialization rights for Lucentis in the United States.Novartisshall hold the rights for territories outside the United States.

Recently, at the American Academy of Ophthalmology (AAO) 2020 OnlineConferenceAt the conference, Biogen and Samsung Bioepis announced for the first time the one-year results of the Phase 3 study of SB11 in the treatment of neovascular age-related macular degeneration (nAMD). The data showed that the study met its primary endpoint: SB11 demonstrated comparability to the reference drug ranibizumab in terms of efficacy, pharmacokinetics, safety, immunogenicity, and other parameters.

Biosimilars are products that have been demonstrated to be equivalent to reference drugs in terms of efficacy and safety, offering the advantages of reducing healthcare costs and promoting sustainable access to treatment. Over the next five years, the U.S. healthcare system is projected to save more than $100 billion due to biosimilars.

In November 2019, Samsung Bioepis and Biogen entered into a new commercialization agreement for two ophthalmic biosimilars, SB11 (ranibizumab) and SB15 (aflibercept), in the United States, Canada, Europe, Japan, and Australia.

In October 2020, the European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for SB11. If approved, SB11 will join the portfolio of biosimilar products developed by Samsung Bioepis and commercialized by Biogen, which includes three widely used anti-TumorTumor Necrosis Factor (TNF) Biosimilars: Benepali (etanercept), Imraldi (adalimumab), Flixabi (infliximab).

Hee Kyung Kim, Senior Vice President of the Clinical Science Department and Head of the Regulatory Affairs Team at Samsung Bioepis, stated: “The United StatesFDA“The acceptance of the SB11 application marks a step forward in our goal to provide affordable treatment options for patients with retinal vascular diseases. If approved, SB11 will become a valuable treatment option for patients with retinal vascular diseases, potentially helping millions of people in the United States.”

Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen, stated, “We areFDA“We are encouraged by the acceptance of the SB11 application, a significant milestone in providing new treatment options for patients with retinal vascular diseases in the United States. Our biosimilar portfolio is designed to ensure the sustainability of the healthcare system and offer patients broader access to effective and more affordable therapies.” (Bioon.com)

Original Source: SAMSUNG BIOEPIS AND BIOGEN ANNOUNCEFDA FILING ACCEPTANCE OF SB11, A PROPOSED BIOSIMILAR REFERENCING LUCENTIS® (RANIBIZUMAB)