OUR PURPOSE PIONEERING SCIENCE PATIENTS OUR PEOPLE ENVIRONMENT COMMUNITY REPORTING 27 ENHANCING OUR STRATEGIC PORTFOLIO BIOGEN 2021 YEAR IN REVIEW Biosimilars Biopharmaceutical drugs, or biologics, may offer effective therapies for patients living with serious conditions, yet can place a significant financial strain on health systems and access can be limited, resulting in poorer health outcomes. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing approved reference product. Biosimilars offer a solution, expanding access for patients and reducing healthcare costs by providing physicians and patients with more affordable treatments 1 . Biogen biosimilars generated €2.6 billion in healthcare savings for European healthcare systems in 2021 and €7.6 billion since they were first introduced. Having successfully developed and delivered complex originator biologics for 44 years, Biogen is one of a handful of companies with the manufacturing capabilities and scientific expertise required to produce biosimilars of advanced biologics. Biosimilars are a strategic imperative for Biogen and proof of our pioneering spirit. Building on six years of continued growth, Biogen is a biosimilars market leader in Europe with our portfolio of three anti-TNF therapies. We aim to broaden our pipeline to bring more biosimilar solutions to patients and health systems worldwide and currently have four additional biosimilar product candidates in various stages of development. – Anti-TNF (tumor necrosis factor) biosimilars: Anti-TNFs are highly effective in the treatment of immune-mediated inflammatory diseases (IMID) such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, inflammatory bowel disease (Crohn’s and ulcerative colitis), ankylosing spondylitis and psoriasis. Use of anti-TNF medicines in Europe increased by 45% since the introduction of biosimilars. Biogen’s European anti-TNF portfolio of Benepali®, Flixabi™ and Imraldi™ covers 15 indications and serves over 247,000 patients. Recognized as a leader with product supply continuity and reliability, since launch, Biogen has supplied nearly 30 million doses in over 26 countries without missing a patient despite the challenges of COVID-19. – Anti-VEGF (vascular endothelial growth factor) biosimilars: Our portfolio is expanding to include anti-VEGF therapies that have revolutionized the treatment of retinal vascular disorders, which are a leading cause of blindness. We aim to market these biosimilars in the EU, the U.S., Canada, Australia and Japan, as well as other major markets. In 2021, BYOOVIZ™ (ranibizumab/ ranibizumab-nuna) received approval from 27 EU member countries, the U.K. and the U.S. and Canada in 2022, making it the first anti-VEGF ophthalmology biosimilar approved in all these countries. BYOOVIZ™ references LUCENTIS® (ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Ranibizumab prevents vision loss in patients with retinal vascular disorders, which can lead to irreversible blindness or visual impairments in adults. Approximately 11 million U.S. adults are affected with AMD, and the prevalence of advanced AMD is growing due to the aging population. Þ READ MORE ABOUT BYOOVIZ – BIIB800: In 2021, Biogen entered into a commercialization and license agreement with Bio-Thera Solutions, Ltd. to develop, manufacture and commercialize BIIB800 (BAT1806), a Phase 3 clinical stage biosimilar candidate referencing tocilizumab (ACTEMRA/ ROACTEMRA), an anti-interleukin-6 receptor (IL-6R) monoclonal antibody. Tocilizumab is indicated for the treatment of moderate to severe rheumatoid arthritis (RA) in adults, as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome and coronavirus disease 2019 (COVID-19). BIIB800 demonstrated equivalent efficacy at weeks 12 and 24 and similar pharmacokinetics, safety and immunogenicity to reference tocilizumab up to week 24 in patients with moderate to severe RA inadequately controlled by methotrexate therapy. If approved, BIIB800 will enable us to expand our global biosimilars footprint worldwide except China. Þ READ MORE ABOUT PHASE 3 STUDY RESULTS 1. American Journal of Managed Care (AJMC) Center for Biosimilars. (2019, June 27). Biosimilars market is ripe for cost savings .
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