AFLIBERCEPT-YSZY

iStock, Natalya Kosarevich The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants. The FDA has pushed back its target decision date for two of Regeneron’s supplemental applications for a high-dose formulation of Eylea. After initially setting a decision date for Aug. 19 , the agency now expects to deliver verdicts in the fourth quarter. The delay applies to Regeneron’s application to use Eylea HD for patients with macular edema after retinal vein occlusion, as well as the proposal to expand its dosing schedule to include a monthly regimen across approved indications. There do not appear to be problems with the safety or efficacy of Eylea HD in the affected applications. Instead, the review extension is linked to findings at a Catalent manufacturing site. Novo Nordisk, which acquired the CDMO giant in February last year, has already responded to the FDA’s observations, but the regulator considered the submission a major amendment to the affected applications. “It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved,” Regeneron wrote on Wednesday. Meanwhile, Eylea HD vials will remain available in the U.S. for the already approved indications and dosing schedules. Regeneron alluded to the delay earlier this month during second-quarter earnings on Aug. 1, revealing that the FDA would need to extend its review for the two Eylea HD applications. At the time, Novo hadn’t yet addressed the FDA’s concerns at the production facility, and Regeneron wasn’t able to provide an updated timeline for the decisions. “Based on our discussions, we believe that there’s nothing significant left to be done,” CEO Leonard Schleifer said during an investor call at the time. “We are expecting, once the resolution of the filling issues has occurred, to receive favorable action, we hope, from the FDA.” Despite an expected approval, the delays still represent a setback for Regeneron’s Eylea franchise, which once dominated the retinal disease market but has since steadily lost market share to Roche’s Vabysmo. Soon, Eylea will also have to contend with biosimilars after the FDA signed off on two interchangeable copycats in May 2024. One of these, Biocon Biologics’ Yesafili, is expected to hit U.S. shelves late next year . The U.S. launch for the other biosimilar, branded Opuviz and marketed by Samsung Bioepis and Biogen, is still uncertain. Still, the updated FDA timeline likely puts the launch of the new Eylea versions ahead of investor expectations, BMO Capital Markets analysts noted on Wednesday. “Given recent biosimilar competition and subsequent market erosion for Eylea, we appreciate a shorter path to regulatory approval as Regeneron attempts to regain market share for the franchise,” the firm wrote. In the second quarter, the Eylea franchise suffered a 25% year-on-year sales dip, though its $1.15 billion in revenue still came 9% ahead of consensus forecasts.

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced today that the company has entered into a license, development and commercialization agreement (DCA) with Harrow (Nasdaq: HROW), for Samsung Bioepis’ ophthalmology portfolio — BYOOVIZ® (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab) and OPUVIZ™ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept) — in the United States. The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected to be completed by the end of 2025. We will work closely with both Biogen and Harrow to ensure a seamless transition and the continued delivery of services to our customers and patients in the US market. In October 2024, Biogen notified Samsung Bioepis of its decision to terminate the 2019 Development and Commercialization Agreement within the US and Canada. Samsung Bioepis has been closely working with Biogen on the transfer of commercialization rights for BYOOVIZ and OPUVIZ back to Samsung Bioepis in these regions. Harrow will assume full responsibility for commercialization of BYOOVIZ and OPUVIZ in the US upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis. BYOOVIZ was approved by the U.S. Food and Drug Administration (FDA) in September 2021 as the first ophthalmology biosimilar in the US for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). BYOOVIZ has been commercially available in the US since June 2022. OPUVIZ was approved in May 2024 for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). “We are pleased to partner with Harrow, a leading eyecare pharmaceutical company with strong capabilities in commercialization of ophthalmic pharmaceutical products in the North American market. We will work closely with both Biogen and Harrow to ensure a seamless transition and the continued delivery of services to our customers and patients in the US market,” said Josh Sang Hyun Lee, Vice President and Business Development Team Leader at Samsung Bioepis. “Samsung Bioepis remains committed to expanding access and widening treatment options for healthcare systems, healthcare professionals, and patients, by providing affordable and high-quality biologic medicines around the world.” About BYOOVIZ (ranibizumab-nuna) BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use. BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection). BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection. Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP. Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE. About OPUVIZ (aflibercept-yszy) OPUVIZ (aflibercept-yszy) injection, for intravitreal use. OPUVIZ (aflibercept-yszy) is biosimilar to EYLEA (aflibercept). OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE. 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 – LinkedIn, X. i Lucentis is a trademark of Genentech, Inc. ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc.