Yesafili (aflibercept-jbvf) / J&J, Biocon - LARVOL DELTA

Clinical Trials of Aflibercept Biosimilars: A Review. (PubMed, J Ocul Pharmacol Ther) - "Following the patent expiration of ranibizumab, multiple anti-VEGF biosimilars have been developed, with the first approved for ophthalmic use entering the market in 2022. Understanding the study designs of biosimilars can mitigate negative perceptions of biosimilars and promote their active implementation. In this review, we provide a comprehensive comparison of the designs of phase III clinical trials of aflibercept biosimilars, including recently published results."

Journal • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis. (PubMed, Clin Ophthalmol) - "Aflibercept biosimilars demonstrated comparable efficacy and safety profiles to reference aflibercept in the treatment of nAMD. These findings suggest that biosimilars may serve as a cost-effective alternative without compromising patient outcomes."

Journal • Retrospective data • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Biocon Biologics gets Health Canada approval for its AMD biosimilar Yesafili (New Indian Express) - "Biocon Biologics, the biosimilars subsidiary of Biocon Ltd, said on Friday that Health Canada has granted a Notice of Compliance (NOC) for its age-related macular degeneration (AMD) drug, Yesafili. The drug is a biosimilar to aflibercept, marketed under the brand name Eylea by US biotech major Regeneron Pharmaceuticals. This approval clears the way for the Canadian launch of Yesafili injection on July 4, 2025, making it the first biosimilar to Eylea approved by Health Canada."

Biosimilar launch • Canada approval • Wet Age-related Macular Degeneration

Systematic review of efficacy and meta-analysis of safety of aflibercept biosimilars relative to reference aflibercept anti-VEGF therapy for neovascular AMD treatment (SOE 2025) - "Conversely, we excluded studies that did not provide visual outcome data following intravitreal injections of biosimilar and reference ranibizumab, those that combined anti-VEGF treatments with laser or steroid injections, studies using sham injections as a control, non-English full texts, and those with non-comparative, observational designs. Our cohort included a total of 2,039 patients diagnosed with neovascular age-related macular degeneration, who received either reference Aflibercept (n = 1,016, 49.8%) or Aflibercept biosimilars (n = 1,023; 50.2%). This systematic review of four RCTs demonstrated no significant difference in visual outcomes, retinal thickness outcomes, as well as meta-analysis of adverse events between biosimilar and reference Aflibercept therapies for nAMD treatment."

Retrospective data • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Biocon Biologics Secures Market Entry Date for Yesafili, an Interchangeable Biosimilar to Eylea, in the U.S. (PRNewswire) - "Biocon Biologics Ltd (BBL)...announced today a settlement and license agreement with Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the United States....Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the United States Court of Appeals for the Federal Circuit (USCAFC) of patent US11084865 ('865 patent) and the pending litigation at the U.S. District Court for the Northern District of West Virginia, Clarksburg Division. This agreement enables the Company to launch in the United States in the second half of calendar year 2026 or earlier in certain circumstances....YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME)..."

Biosimilar launch • Licensing / partnership • Patent • Age-related Macular Degeneration • Diabetic Macular Edema • Retinal Vein Occlusion

Randomized Trial of MYL-1701P (Proposed Aflibercept Biosimilar) vs. Aflibercept Through 76 Weeks in DME, Including Switch From Aflibercept (AAO 2024) - "Adjusted mean difference in change in best corrected visual acuity between baseline and Week 76 (switch minus continuation arm) was −1.20 ETDRS letters (90% CI, −6.15 to 3.75). Conclusion Similar safety, efficacy and immunogenicity profiles were observed between those who continued to receive MYL-1701P and those who switched to it from aflibercept."

Clinical • Ophthalmology

Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P3 | "To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME. These findings support use of MLY-1701P as an alternative to reference aflibercept. ClinicalTrials.gov Identifier: NCT03610646."

Clinical • Journal • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Metabolic Disorders • Ophthalmology • Retinal Disorders • Type 2 Diabetes Mellitus

Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili. Enters U.S. Ophthalmology Market (PRNewswire) - "Biocon Biologics Ltd (BBL)...announced that the U.S. Food and Drug Administration (US FDA) has approved the Company's first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA (aflibercept)....The Company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement."

Biosimilar launch • FDA approval • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Biocon Biologics Secures Canada Market Entry Date for YESAFILI, a Proposed Biosimilar to EYLEA (Biocon Press Release) - "Biocon Biologics Ltd (BBL)...has announced the signing of a settlement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. This Agreement paves the way for the introduction of YESAFILI, a proposed biosimilar to EYLEA (aflibercept) Injection, into the Canadian market. Under the terms of the agreement, Biocon Biologics has secured a launch date for YESAFILI 2 mg NDS for vials and prefilled syringes (yet to be filed), set no later than July 1, 2025."

Launch Canada • Licensing / partnership • Age-related Macular Degeneration • Diabetic Macular Edema • Ophthalmology • Wet Age-related Macular Degeneration

Biocon Biologics Announces Positive CHMP Opinion for YESAFILI, Biosimilar Aflibercept (PRNewswire) - "Biocon Biologics Ltd (BBL)...announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI®, an aflibercept biosimilar....The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected by the end of September 2023."

European regulatory • Age-related Macular Degeneration • Diabetic Macular Edema • Ophthalmology • Wet Age-related Macular Degeneration

Extension Study of MYL-1701P-3001 for Safety and Efficacy (clinicaltrials.gov) - P3 | N=52 | Completed | Sponsor: Mylan Pharmaceuticals Inc | Active, not recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

Extension Study of MYL-1701P-3001 for Safety and Efficacy (clinicaltrials.gov) - P3 | N=52 | Active, not recruiting | Sponsor: Mylan Pharmaceuticals Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2022 ➔ Jun 2022

Enrollment closed • Trial completion date • Diabetic Macular Edema • Ophthalmology

Pipeline therapies for neovascular age related macular degeneration. (PubMed, Int J Retina Vitreous) - "Prior treatments have included focal laser therapy, verteporfin (Visudyne, Bausch and Lomb, Rochester, New York) ocular photodynamic therapy, transpupillary thermotherapy, intravitreal steroids and surgical excision of choroidal neovascular membranes. Currently, the major therapies in AMD focus on the VEGF-A pathway, of which the most common are bevacizumab (Avastin; Genentech, San Francisco, California), ranibizumab (Lucentis; Genentech, South San Francisco, California), and aflibercept (Eylea; Regeneron, Tarrytown, New York)...Cheaper alternatives, including ranibizumab biosimilars, include razumab (Intas Pharmaceuticals Ltd., Ahmedabad, India), FYB 201 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), SB-11 (Samsung Bioepsis, Incheon, South Korea), xlucane (Xbrane Biopharma, Solna, Sweden), PF582 (Pfnex, San Diego, California), CHS3551 (Coherus BioSciences, Redwood City, California). Additionally, aflibercept biosimilars under development include..."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - P3; N=355; Completed; Sponsor: Mylan Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetic Macular Edema • Ophthalmology

Brolucizumab vs aflibercept and ranibizumab for neovascular age-related macular degeneration: a cost-effectiveness analysis. (PubMed, J Manag Care Spec Pharm) - "Wykoff reports personal fees from Corcept Therapeutics, DORC, EyePoint, Gyroscope, IVERIC Bio, Merck, Notal Vision, ONL Therapeutics, Oxurion, Palatin, PolyPhotonix, Takeda, Thea Open Innovation; grants from Aerie Pharmaceuticals, Aldeyra, Gemini Therapeutics, Graybug Vision, IONIS Pharmaceutical, LMRI, Mylan, Neurotech Pharmaceuticals, Outlook Pharmaceuticals, Samsung Bioepis, Senju, Taiwan Liposome Company, Xbrane BioPharma, Santen; and grants and personal fees from Adverum, Allergan, Apellis, Chengdu Kanghong Biotechnologies (KHB), Clearside Biomedical, Genentech, Kodiak Sciences, NGM Biopharmaceuticals, Novartis, Opthea, Recens Medical, Regenxbio, Roche, and Regeneron, unrelated to this work. This research was presented as a virtual poster at the AMCP 2020 Annual Meeting, April 2020."

HEOR • Journal • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Extension Study of MYL-1701P-3001 for Safety and Efficacy (clinicaltrials.gov) - P3; N=70; Recruiting; Sponsor: Mylan Inc.

Clinical • New P3 trial • Diabetic Macular Edema • Ophthalmology

Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - P3; N=355; Active, not recruiting; Sponsor: Mylan Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ Sep 2021; Trial primary completion date: Feb 2020 ➔ Nov 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology