Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen.
“The EMA filing acceptance for SB11 (ranibizumab) further demonstrates the productive collaboration between Samsung Bioepis and Biogen and brings us closer to our shared goal of offering new affordable treatment options for people with retinal vascular disorders,” said Hee Kyung Kim, Senior Vice President, Clinical Sciences and Regulatory Affairs Division Lead at Samsung Bioepis. “We believe SB11 has the potential to be a meaningful new offering for patients with retinal vascular disorders, and we look forward to continued engagement with the EMA throughout the review process.”
“The EMA acceptance of the SB11 (ranibizumab) application is an important step as we work to bring a new potential treatment option for patients with retinal vascular disorders and would represent a significant addition to our biosimilar portfolio,” said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen. “We believe our biosimilar offerings are essential as we collaborate with payers and health authorities globally with the goal of creating budget headroom to fund innovation and ensure sustainable healthcare systems.”
Samsung Bioepis announced in November 2019 that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (U.S.), Canada, Europe, Japan and Australia.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen.
About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.
