Enzeevu (aflibercept-abzv) / Sandoz - LARVOL DELTA

Sandoz…announced the European launch of Afqlir (aflibercept). Afqlir, a 2 mg vial kit and pre-filled syringe for intravitreal injection, was approved by the European Commission in November 2024 for the same indications in adult patients as the reference medicine, Eylea, namely the treatment of various retinal diseases to prevent disease-related blindness (Sandoz Press Release) - "Aflibercept is considered a gold standard for treating various neovascular retinal diseases. Conditions like age-related macular degeneration (AMD), retinal vein occlusion (RVO) and diabetic macular edema (DME) are leading causes of vision loss and their global prevalence is increasing....Afqlir will be launched across Europe, beginning in the UK today, followed by other major markets such as Germany and France, with additional rollouts to follow in 2026."

Biosimilar launch • Diabetic Macular Edema • Macular Degeneration • Retinal Vein Occlusion

US SETTLEMENT: AFLIBERCEPT (Sandoz Press Release) - "Sandoz recently announced that it has reached an agreement with Regeneron Pharmaceuticals, Inc., to resolve all patent disputes between the two companies relating to the US FDA-approved Sandoz aflibercept biosimilar. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Eylea in the fourth quarter of 2026, or earlier in certain circumstances."

Biosimilar launch • Wet Age-related Macular Degeneration

Development of Biosimilar Aflibercept SDZ-AFL. (PubMed, Curr Ther Res Clin Exp) - "In 2024, Sandoz biosimilar aflibercept (SDZ-AFL; SOK583A1, Enzeevu/Afqlir) was approved by the US Food and Drug Administration and the European Medicines Agency as a biosimilar of reference aflibercept (Ref-AFL; Eylea, a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc) based on a comprehensive package of data. This comprehensive totality of evidence has established biosimilarity between SDZ-AFL and Ref-AFL based on comparable physicochemical and biological characteristics, as well as similarity in clinical efficacy, safety, and immunogenicity. The introduction of aflibercept biosimilars to the market is anticipated to reduce barriers to access, potentially increasing the number of appropriate patients with retinal diseases benefiting from this biologic therapy."

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

Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar (Sandoz Press Release) - "Patent infringement proceedings were initially filed by Regeneron in the US Federal District Court for the District of New Jersey in August of 2024, pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Regeneron that the company infringed up to 46 patents expiring as late as 2040, protecting reference medicine Eylea. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Eylea in the fourth quarter of 2026, or earlier in certain circumstances."

Commercial • Patent • Age-related Macular Degeneration

SDZ-AFL: An Aflibercept Biosimilar. (PubMed, Clin Drug Investig) - "SDZ-AFL (SOK583A1; Afqlir®) is a biosimilar of the reference intravitreal aflibercept, a vascular endothelial growth factor inhibitor...The tolerability, safety and immunogenicity profiles of SDZ-AFL were similar to those of reference aflibercept. The role of reference aflibercept in the management of neovascular retinal diseases is well established, and SDZ-AFL provides an effective biosimilar alternative for patients requiring ophthalmic aflibercept therapy."

Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

EFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: 52-Week Results From the Phase 3 Mylight Study. (PubMed, Retina) - "Proposed biosimilar aflibercept matched reference aflibercept in efficacy, safety, and pharmacokinetics in participants with neovascular age-related macular degeneration. Therefore, this Phase 3 study confirmed biosimilarity of SDZ-AFL to Ref-AFL."

Clinical • Journal • P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Sandoz receives FDA approval for Enzeevu (aflibercept-abzv), further strengthening US biosimilar position (GlobeNewswire) - "Sandoz...today announced that the US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. Enzeevu is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, the FDA provisionally determined Enzeevu would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products."

FDA approval • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Sandoz announces positive results from Mylight Phase lll study for biosimilar aflibercept (GlobeNewswire) - P3 | N=485 | MYLIGHT (NCT04864834) | Sponsor: Sandoz | "Sandoz...releases positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration – a key development in its efforts to address this area of unmet medical need....The Mylight Phase III confirmatory efficacy and safety study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and the reference biologic, Eylea®. Safety, immunogenicity, and pharmacokinetics results further confirm that there is no clinically meaningful difference between the products....Sandoz expects to file for regulatory approval for biosimilar aflibercept in the US and EU in the coming months."

BLA • European regulatory • P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Mylight: Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=485 | Completed | Sponsor: Sandoz | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Mylight: Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=485 | Active, not recruiting | Sponsor: Sandoz | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit (clinicaltrials.gov) - P3 | N=36 | Completed | Sponsor: Sandoz | Recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit (clinicaltrials.gov) - P3 | N=38 | Recruiting | Sponsor: Sandoz | Trial completion date: Aug 2022 ➔ Nov 2022 | Trial primary completion date: Aug 2022 ➔ Nov 2022

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit (clinicaltrials.gov) - P3 | N=38 | Recruiting | Sponsor: Sandoz | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe (clinicaltrials.gov) - P3 | N=30 | Completed | Sponsor: Sandoz | Not yet recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Mylight: Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: Sandoz | Trial completion date: Jan 2024 ➔ Jul 2023

Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit (clinicaltrials.gov) - P3 | N=38 | Not yet recruiting | Sponsor: Sandoz

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Mylight: Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: Sandoz | Trial completion date: May 2023 ➔ Jan 2024

Trial completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe (clinicaltrials.gov) - P3; N=30; Not yet recruiting; Sponsor: Sandoz

Clinical • New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Roles for VEGF Inhibitors in the Management of Retinal Diseases - Episode 9: A Review of Clinical Trial Data in Non-Proliferative Diabetic Retinopathy (HCPLive) - "Diana V. Do, MD: The reduction in vision-threatening complications is the most clinically meaningful for us and for the patients. As you said, the primary end point was looking at severity scale of their diabetic eye disease and the reduction, and these studies met those primary end points. But when we're talking to patients and we're understanding how we can preserve their vision, vision-threatening complications is where the money is. That's where we can help patients preserve their central and peripheral vision."

Video

Mylight: Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3; N=460; Recruiting; Sponsor: Sandoz; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Mylight: Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3; N=460; Not yet recruiting; Sponsor: Sandoz

Clinical • New P3 trial • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration