An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Vial Kit

This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.

Start Date16 May 2022

Sponsor / Collaborator

Sandoz Group AG

NCT05161806

/ CompletedPhase 3

This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.

Start Date11 Mar 2022

Sponsor / Collaborator

Sandoz Group AG

JPRN-jRCT2031210120

/ CompletedPhase 3IIT

A 52 week multicenter, randomized, double masked, 2 arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea, administered intravitreally, in patients with neovascular age related macular degeneration

Start Date02 Nov 2021

Sponsor / Collaborator-

100 Clinical Results associated with Aflibercept-abzv

100 Translational Medicine associated with Aflibercept-abzv

100 Patents (Medical) associated with Aflibercept-abzv

Literatures (Medical) associated with Aflibercept-abzv

01 Sep 2025·Clinical Drug Investigation

SDZ-AFL: An Aflibercept Biosimilar

Review

Author: Syed, Yahiya Y

SDZ-AFL (SOK583A1; Afqlir^®) is a biosimilar of the reference intravitreal aflibercept, a vascular endothelial growth factor inhibitor. SDZ-AFL has been approved in the EU for the treatment of the same indications in adults as reference aflibercept: neovascular age-related macular degeneration (nAMD), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation. SDZ-AFL has similar physicochemical and pharmacodynamic properties to those of reference aflibercept, and pharmacokinetic similarity has been demonstrated in patients with nAMD. SDZ-AFL demonstrated clinical efficacy equivalent to that of reference aflibercept in patients with nAMD and was generally well tolerated in this population. 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.

01 Jan 2025·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Development of Biosimilar Aflibercept SDZ-AFL

Review

Author: Alliger, Peter ; Wersig, Cornelia ; Allmannsberger, Lisa ; Silva, Rufino ; Heyn, Jens ; Dodeller, Francis ; Urosevic, Dragan

Purpose:

Aflibercept is a recombinant fusion protein that binds with high affinity to vascular endothelial growth factor A (VEGF-A), and other growth factors, reducing pathological neovascularization and abnormal vascular permeability. Aflibercept is approved as a first-line treatment for several retinal diseases, including neovascular age-related macular degeneration (nAMD); however, the high costs of these biologic agents can impede patient access. 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.

Methods:

This narrative review summarizes the totality of evidence demonstrating biosimilarity between SDZ-AFL and Ref-AFL, including physicochemical and biological characterization data from analytical in vitro studies, results of an ocular pharmacokinetic (PK) study in rabbits, and clinical efficacy, safety, immunogenicity, and systemic PK data from Phase III clinical studies.

Results:

Analytical evaluation demonstrated that SDZ-AFL has structural homology with Ref-AFL, including identical amino acid sequences, indistinguishable higher-order structures, and highly similar levels of structural variants. SDZ-AFL and Ref-AFL also demonstrated highly similar in vitro biologic activities, including target binding affinity, and potency in terms of neutralization of VEGF-A. In a single-dose ocular PK study in rabbits, vitreal exposure was comparable between SDZ-AFL and Ref-AFL after intravitreal administration. A 52-week Phase III clinical study (Mylight) evaluated the efficacy, safety, immunogenicity, and systemic PK of SDZ-AFL and Ref-AFL in 484 participants with nAMD. The primary endpoint was mean change from baseline to week 8 in best corrected visual acuity (BCVA): the difference between the SDZ-AFL and Ref-AFL groups in this endpoint was -0.3 letters (90% CI -1.5 to 1.0), which met predefined bioequivalence margins. Secondary efficacy endpoints, including changes from baseline in BCVA and central subfield foveal thickness over the whole 52-week study, were also similar for SDZ-AFL and Ref-AFL. Two subsequent "in-use" studies confirmed the safe use of SDZ-AFL provided in either a vial kit or a prefilled syringe.

Conclusion:

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.

01 Oct 2024·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES

EFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Article

Author: Cen, Liyi ; Wolf, Armin ; Dodeller, Francis ; Bordon, Arnaldo F. ; Allmannsberger, Lisa ; Kaiser, Peter K. ; Heyn, Jens ; Urosevic, Dragan ; Silva, Rufino

Purpose::

The Phase 3 Mylight study was designed to confirm clinical equivalence of proposed biosimilar aflibercept (SOK583A1; Sandoz [proposed biosimilar aflibercept, SDZ-AFL]) to its reference biologic (Eylea; Regeneron Pharmaceuticals, Inc; Bayer AG [reference aflibercept, Ref-AFL]).

Method::

Mylight was a prospective, double-masked, 2-arm, parallel Phase 3 study. Participants with neovascular age-related macular degeneration were randomized 1:1 to receive eight injections of SDZ-AFL (n = 244) or Ref-AFL (n = 240) over 48 weeks. The primary endpoint was mean change in best-corrected visual acuity score from baseline to Week 8. Secondary endpoints included anatomical outcomes, best-corrected visual acuity at Weeks 24 and 52, safety, and pharmacokinetics.

Results::

Similarity in mean change in best-corrected visual acuity score was established between SDZ-AFL (n = 235) and Ref-AFL (n = 226) at Week 8 (difference: −0.3 [90% CI, −1.5 to 1.0]) and Week 52. No clinically meaningful differences occurred between groups in anatomical outcomes. Safety profiles were similar, with comparable incidences of treatment-related adverse events (SDZ-AFL: 2.5%; Ref-AFL: 2.9%). The incidence of anti-drug antibodies was similar between groups. Systemic free aflibercept concentrations 24 hours postdose were low and comparable between SDZ-AFL and Ref-AFL.

Conclusion::

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.

News (Medical) associated with Aflibercept-abzv

02 Feb 2026

·investors.alvotech.com

Alvotech enters supply and commercialization agreements for Canada and Australia & New Zealand covering multiple biosimilar candidates

REYKJAVIK, Iceland, Feb. 02, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has entered into supply and commercialization agreements with Sandoz covering multiple biosimilar candidates in Canada, and in Australia and New Zealand. “These agreements with Sandoz further advance Alvotech’s strategy of securing commercial pathways for its biosimilars portfolio across global markets ahead of regulatory approval,” said Róbert Wessman, Chairman. “These partnerships reflect the strength of our integrated development and manufacturing platform and our ability to work with experienced regional partners to expand patient access while maintaining capital discipline.” In Canada, the agreement covers one biosimilar candidate in ophthalmology supplied as a prefilled syringe for intravitreal injection. In Australia and New Zealand, the agreement encompasses three biosimilar candidates across immunology and gastroenterology, in multiple formulations. Sandoz will lead regulatory filings and commercial activities in the territories in close coordination with Alvotech. The collaboration is intended to support broad patient access following regulatory approvals and market launches across the region. Under the agreements, Sandoz will be responsible for regulatory submissions, commercialization and distribution in the respective jurisdictions. Alvotech will retain responsibility for development, global clinical activities and manufacturing and will supply finished product to Sandoz under exclusive supply arrangements. With a strong presence in Canada, Australia and New Zealand, Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad (US) Patrik Ling (SE) Benedikt Stefansson (IS) alvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube. Alvotech Forward-Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

BiosimilarLicense out/in

02 Feb 2026

·www.biospace.com

Sandoz Canada launches first ophthalmology biosimilar

Sandoz Canada expands portfolio launching Enzeevu ® , company's first ophthalmology biosimilar Enzeevu ® is approved for all indications of reference medicine EYLEA ® 1 , including neovascular age-related macular degeneration and diabetic macular edema Launch supports improved affordability and access to retinal disease treatments across Canada SAINT-HUBERT, QC , Feb. 2, 2026 /CNW/ - Sandoz, the global leader in affordable medicines, today announced the launch of Enzeevu ® (aflibercept) in Canada, its first ophthalmology biosimilar, expanding access to affordable treatment options for people living with serious retinal diseases across Canada. Enzeevu ® is a biosimilar to the reference medicine EYLEA ® and is approved for all indications of the reference medicine: neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) diabetic macular edema (DME) myopic choroidal neovascularization (myopic CNV) These conditions are among the leading causes of vision impairment in Canada, particularly affecting older adults and people living with diabetes. 2 "With the growing prevalence of retinal diseases, access to effective and affordable treatment options has never been more important," said Michel Robidoux , President and General Manager of Sandoz Canada. "By offering a biosimilar to one of the most widely used therapies in this field, we are helping to improve affordability and access for thousands of patients nationwide." Enzeevu ® is supplied as a 2 mg/0.05 mL solution for intravitreal injection in a single-use pre-filled syringe, delivering a single dose of 2 mg aflibercept. The product has a similar appearance to the reference medicine, supporting continuity of care and facilitating the transition for patients currently receiving treatment. Patients and healthcare professionals will also benefit from a comprehensive patient support program during treatment with Enzeevu ® , providing practical support and guidance throughout the entire patient experience. This launch reinforces the Sandoz Purpose of pioneering access for patients and reflects the company's continued commitment to expanding its biosimilars portfolio into new therapeutic areas, including ophthalmology. As a leader in affordable medicines, Sandoz Canada continues to work with healthcare partners to support sustainable healthcare systems and improved patient outcomes. DISCLAIMER This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management's views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. ABOUT SANDOZ CANDA As a Canadian leader in off-patent medicines, Sandoz Canada has a product portfolio that includes over 700 generics and biosimilars spanning multiple therapeutic areas, such as anti-infective, cardiovascular, central nervous system, immunology and oncology. In 2025, 59 million Sandoz prescriptions were issued in Canada (source: IQVIA Compuscript TRx, MAT 2025). Sandoz Canada employs 300 people across the country and at its head office in Saint-Hubert, Quebec. It is a trusted partner for pharmacists, physicians and hospitals for quality medicine and outstanding customer service and is committed to ensuring a reliable supply. For more information about Sandoz Canada, visit . REFERENCES 1 EYLEA ® is a registered trademark of Bayer Inc. 2 Fighting Blindness in Canada. A Report Card on Vision Health in Canada 2023 . SOURCE Sandoz Canada

Drug Approval

22 Oct 2025

·www.fiercepharma.com

Regeneron settles Eylea patent dispute with Celltrion, allowing another biosimilar to launch at end of 2026

Regeneron's agreement with Celltrion follows recent settlements with other Eylea biosimilar makers including Sandoz and Biocon Biologics. Regeneron has settled its patent dispute with Celltrion, giving the go-ahead for another biosimilar to its blockbuster eye drug Eylea (aflibercept) to hit the U.S. market in just over a year.The deal settles all patent litigation between the two companies and allows Celltrion to launch its biosimilar on Dec. 31, 2026, Regeneron said in an Oct. 20 statement. Other terms of the agreement, including financial considerations, remain confidential.South Korean drugmaker Celltrion won U.S. approval for its biosimilar on Oct. 9, with the FDA signing off on the drug's use in the same indications Eylea holds for neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. The Eylea biosim will be marketed under the name Eydenzelt. In trials, the drug “met the predefined equivalence criteria” to Eylea and showed similar results to the reference product in secondary endpoints of efficacy, safety and immunogenicity, according to Celltrion. Celltrion is the latest to win an FDA nod for its aflibercept product out of the biosim developers Regeneron has sued. Celltrion, Sandoz, Amgen, Formycon, Samsung Bioepis and Mylan Pharmaceuticals—plus partner Biocon Biologics—have all been the subjects of Regeneron’s attempts to block out the biosimilar competition in the courts.Only Amgen, however, has emerged with a legal victory over Regeneron, enabling the company to sell the only marketed Eylea biosimilar in the U.S. But, with Regeneron's recent settlements, the competition is poised to intensify next year. Sandoz’s Enzeevu, for one, is allowed to launch in the fourth quarter of 2026, or earlier in “certain circumstances,” under that company's recent agreement with Regeneron. Enzeevu is an interchangeable biosimilar, meaning it can be substituted at the pharmacy counter without a new prescription from a doctor.Biocon and Mylan became the first to settle with Regeneron back in April, allowing their interchangeable Yesafili to launch in the second half of 2026. Regeneron is still blocking Samsung Bioepis’ Opuviz and Formycon’s Ahzantive biosimilars from launching and hasn’t given up on its dispute with Amgen, filing another complaint as recently as June. Eylea pulled down $1.1 billion in U.S. sales last quarter, a 25% fall from the same period last year.

Drug ApprovalPatent InfringementBiosimilarLicense out/in

100 Deals associated with Aflibercept-abzv

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Dystrophy, Macular	Canada	Sandoz AG	01 Oct 2025
Vision, Low	Australia	Sandoz Pty Ltd.	27 May 2025
Diabetic macular oedema	European Union	Sandoz GmbH	13 Nov 2024
Diabetic macular oedema	Iceland	Sandoz GmbH	13 Nov 2024
Diabetic macular oedema	Liechtenstein	Sandoz GmbH	13 Nov 2024
Diabetic macular oedema	Norway	Sandoz GmbH	13 Nov 2024
Myopic choroidal neovascularization	European Union	Sandoz GmbH	13 Nov 2024
Myopic choroidal neovascularization	Iceland	Sandoz GmbH	13 Nov 2024
Myopic choroidal neovascularization	Liechtenstein	Sandoz GmbH	13 Nov 2024
Myopic choroidal neovascularization	Norway	Sandoz GmbH	13 Nov 2024
Retinal vein occlusion-related macular edema	European Union	Sandoz GmbH	13 Nov 2024
Retinal vein occlusion-related macular edema	Iceland	Sandoz GmbH	13 Nov 2024
Retinal vein occlusion-related macular edema	Liechtenstein	Sandoz GmbH	13 Nov 2024
Retinal vein occlusion-related macular edema	Norway	Sandoz GmbH	13 Nov 2024
Wet age-related macular degeneration	United States	Sandoz, Inc.	09 Aug 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04864834 (Mylight, Corporate Publications) Manual	Phase 3	Wet age-related macular degeneration	485	aflibercept	vljklsfoyi(ekdzuygxxz) = 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®. utillinwna (unkmuhqdgz ) Met	Positive	15 Aug 2023
				Eylea
NCT05282004 (CTgov)	Phase 3	Wet age-related macular degeneration	36	SOK583A1	mxtrstmbdc = mwbmyxnjqn tnjycimndy (jtsffysecz, lmaikqkcao - qrtjgtsdqi) View more	-	10 May 2023
NCT05161806 (CTgov)	Phase 3	Wet age-related macular degeneration	30	Prefilled Syringe (PFS)+SOK583A1 (40 mg/mL)	webbpjnxwb = zlycmrasao kbphlbipyn (dxtfqxpdna, cmmaafakru - zkvglnamiz) View more	-	18 Nov 2022
PROOF study (EURETINA2021)	Not Applicable	Wet age-related macular degeneration anti-VEGF	600	Ranibizumab	wufbkysfph(bvqmpegqho) = qbfywnhhng qrwhuwmiuf (btnpgwvplf, 20.69) View more	Positive	01 Sep 2021
				Aflibercept	wufbkysfph(bvqmpegqho) = zsxrymieiy qrwhuwmiuf (btnpgwvplf, 20.69) View more
EURETINA2021	Not Applicable	-	-	Aflibercept	dedqqwxoso(ibleqzxxza) = thxvftnpwu fbnwvhuisd (djhrhotuyu, 12.5) View more	-	01 Sep 2021
				Ranibizumab-PFS	mzocxnxiea(skktytziri) = twcrhvksnm jtxqvfxqsn (ucbprdossk )
OSPREY (ARVO2021)	Phase 2	Wet age-related macular degeneration	81	Brolucizumab	pvqasdeviw(hegkfvtphj) = inedwaunix wgwhvzbhxb (hjnlouiahf ) View more	-	01 Jun 2021
				Aflibercept	vodmjzgslq(pvezvgwaya) = zhfzewpyqa evlboapyic (luqrlhxpzy ) View more
OSPREY (ARVO2020)	Phase 2	Wet age-related macular degeneration	-	Brolucizumab 6 mg	mgjozutdel(nyrdmawbho) = dujqzepbps vdmcpyfmxs (jldlqbycnm ) View more	Positive	01 Jun 2020
				Aflibercept 2 mg	mgjozutdel(nyrdmawbho) = kdmnvbffrg vdmcpyfmxs (jldlqbycnm ) View more
ARVO2016	Not Applicable	Wet age-related macular degeneration	110	Ranibizumab	ridgjftibi(xzbsytkfcs) = dkzvpihuad pbcybzqlpv (qbutlxivya, 258.63 - 284.95) View more	Positive	01 May 2016
				Aflibercept	ridgjftibi(xzbsytkfcs) = vduexxzyey pbcybzqlpv (qbutlxivya, 235.03 - 257.62) View more

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