Ranibizumab-nuna

INCHEON, South Korea and CAMBRIDGE, MA, USA I September 20, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea 2 (aflibercept), also known as SB15. OPUVIZ has been recommended for approval in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). “We are pleased to have our second ophthalmology biosimilar OPUVIZ recommended for approval in Europe. This marks another significant milestone for Samsung Bioepis and more importantly for people living with retinal disorders as we are making a step forward in enhancing the availability of the essential treatment,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies. We will continue our work to transform the way biologic therapies are brought to patients and enhance the lives of patients, through our pioneering and innovative use of science and technology,” she added. “We are excited about the positive CHMP recommendation for OPUVIZ in Europe and the potential for it to serve as a meaningful therapeutic option for individuals impacted by retinal vascular disorders,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Biosimilars could help broaden access and offer significant healthcare savings through the treatment of these complex and often debilitating ophthalmic diseases.” The CHMP’s positive opinion was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL. 3, 4 This CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant a marketing authorization for OPUVIZ. If a marketing authorization is granted by the EC, OPUVIZ would become the second ophthalmology biosimilar approved in Europe and fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen, which includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the U.S., Canada, Europe, Japan and Australia. About the SB15 Phase 3 study 3 The study is a randomized, double-masked, parallel group phase 3 study conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were randomized 1:1 to receive either SB15 (n = 224) or AFL (n = 225). At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56. Key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra or sub-retinal fluid. 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, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . SOURCE: Samsung Bioepis

Byooviz was the first biosimilar to Roche and Novartis' blockbuster eye drug Lucentis. A new antitrust investigation in Italy has ensnared Novartis, Genentech, Biogen and Samsung Bioepis for allegedly colluding to suppress competition of a Lucentis biosimilar in the country. Italy’s antitrust agency, called the Italian Competition Authority or AGCM, accused the companies and some of their Italian, Dutch and U.K. business units of coordinating their commercial strategies to stall the launch of Samsung Bioepis and Biogen's Byooviz, Reuters first reported. The delay could have not only limited availability and access for patients, but could have affected healthcare spending, Reuters reported from an AGCM statement. Office searches have already been initiated in Italy and the Netherlands, the AGCM said. Roche’s Genentech and Novartis each have their hands on the blockbuster injectable eye drug Lucentis, with Genentech marketing it in the U.S. and Novartis responsible for its commercialization in other markets. Byooviz is manufactured by Samsung Bioepis and commercialized by Biogen. Biogen originally formed Samsung Bioepis with Samsung Biologics in 2021 and sold its equity stake in 2022, shortly before Byooviz launched in the U.S. Byooviz was approved in Europe and the U.S. in 2021 and was the first ophthalmology biosimilar and the first copy of Lucentis, which treats several eye conditions including wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. A Novartis representative confirmed that the company is cooperating with the Italian Competition Authority and has provided the requested information. “Novartis strongly believes that it has acted appropriately and in accordance with competition law and in the best interests of patients,” the representative said. “Novartis is committed to improving patient health, adhering to high ethical standards and in compliance with laws and regulations. Samsung Bioepis is “fully cooperating” with the probe, as is Biogen, the companies said over email. Roche and Genentech do not comment on regulatory or legal investigations, a spokesperson said, but see biosimilar competition as “a normal part of a biologic treatment’s life cycle." The company further said it believes biosimilars “have an important role to play in supporting the financial sustainability of healthcare systems while making headroom for innovation.” “Our focus remains the discovery and development of novel medicines and treatments that improve the health and quality of life of people living with certain conditions, in areas where there is an unmet medical need,” the spokesperson added.