Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab)

Rhea-AI Summary

On November 18, 2020, Samsung Bioepis and Biogen announced that the FDA accepted the Biologics License Application for SB11, a biosimilar to Lucentis® (ranibizumab), aimed at treating retinal vascular disorders, a leading cause of blindness in the U.S.

This milestone could significantly improve access to affordable therapies, with projected savings exceeding $100 billion over five years from biosimilars in the U.S. If approved, SB11 is expected to help millions of patients.

Positive

• FDA acceptance of SB11 for review marks significant progress in treatment options for retinal vascular disorders.
• Projected savings from biosimilars in the U.S. are expected to exceed $100 billion over the next five years, enhancing market opportunities.
• SB11 could provide a valuable treatment option for millions suffering from retinal vascular disorders.

Negative

• Drug development carries inherent risks; approval is uncertain and will depend on further regulatory reviews and clinical outcomes.

INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Lucentis®¹ (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are a leading cause of blindness in the United States.

Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product, with the advantage that they offer cost savings and promote sustainable access to therapies. Savings in the United States over the next five years as a result of biosimilars are projected to exceed $100 billion.³

“The 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,” said Hee Kyung Kim, Senior Vice President and Clinical Sciences Division and Regulatory Affairs Team Leader, at Samsung Bioepis. “If approved, SB11 will be a valuable treatment option for people with retinal vascular disorders, potentially helping millions of people in the U.S.”

“We are encouraged by the FDA’s filing acceptance of SB11, a key milestone in the process for providing a new potential treatment option for patients in the United States with retinal vascular disorders,” said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen. “Our biosimilar portfolio aims to ensure sustainability of healthcare systems by offering broader patient access to effective and more affordable treatment options.”

In October 2020 the Marketing Authorization Application (MAA) for SB11 was accepted for review by the European Medicines Agency (EMA). If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe; BENEPALI™, IMRALDI™ and FLIXABI™.

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 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. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

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. Today Biogen 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.

We routinely post information that may be important to investors on our website at www.biogen.com . To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

Safe Harbor

This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits, safety and efficacy of SB11; the timing and status of current and future regulatory filings; risks and uncertainties associated with drug development and commercialization, including SB11; the potential of Biogen’s commercial business and pipeline programs, including BENEPALI™, IMRALDI™, FLIXABI™ and SB11; the anticipated benefits and potential of Biogen’s collaboration arrangements with Samsung Bioepis; Biogen’s strategy and plans; and potential cost healthcare savings related to biosimilars. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage

FAQ

What is the significance of the FDA's acceptance of SB11 for Biogen's stock (BIIB)?

The FDA's acceptance of SB11 signifies progress in Biogen's biosimilar portfolio, potentially enhancing revenue streams and market position, which is positive for BIIB's stock.

When was SB11's Biologics License Application submitted to the FDA?

The Biologics License Application for SB11 was accepted for review by the FDA on November 18, 2020.

How much savings are projected from biosimilars in the U.S. over the next five years?

Savings from biosimilars in the U.S. are projected to exceed $100 billion over the next five years.

What therapeutic area does SB11 target?

SB11 targets retinal vascular disorders, which are a leading cause of blindness in the U.S.