Aflibercept biosimilars
An eye injection for wet macular degeneration and diabetic eye disease, with a burst of biosimilars in 2024 and 2025 and the first Indian product in 2025.
About aflibercept
Aflibercept is a fusion protein built from pieces of the receptors that catch VEGF, the growth factor behind abnormal blood vessels in the eye. It binds VEGF more tightly than ranibizumab and lasts longer, so injections can be spaced further apart.
Injected into the eye, it traps VEGF and related growth factors before they can make blood vessels grow and leak. Sight stabilises or improves in most patients.
A small injection into the eye, monthly for the first three doses and then every two months or longer, from a vial or a pre-filled syringe. The original product also comes in a higher-dose form that has no biosimilar.
Wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy, retinal vein occlusion and abnormal vessels in short-sighted eyes.
A biosimilar is compared in the laboratory and in a clinical study of sight in patients with macular degeneration over about two months, with full testing of the syringe. Immune reactions have not been an issue.
The reference product is Eylea, from Regeneron in the United States and Bayer elsewhere. Patent litigation set the US launch timetable, and the first launch came in late 2024 after a court ruled in the biosimilar's favour.
Aflibercept is the most active eye biosimilar of the decade: six US products and a dozen European ones in under two years, mostly from the same companies that copied ranibizumab. India joined in 2025 with Zydus's first domestic permission and Biocon's imported product. The originator's higher-dose version, with no biosimilar, is its defence.
Clinical details are summarised from the reference product's prescribing information. Approval dates, numbers and presentations are in the tables below, each with its source.
Competitive outlook
- Todaythirteen aflibercept biosimilars are approved in at least one of the seven markets.
- Nearest to marketAVT29, QL1207 have reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from thirteen to fifteen.
No published switching study for this molecule yet.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| FDA | Yesafili | Biocon Biologics Inc. | May 2024 | 761274 | Interchangeable | Approved | S001, S016 |
| FDA | Opuviz | Samsung Bioepis Co., Ltd. | May 2024 | 761350 | Interchangeable | Approved | S001, S016 |
| FDA | Ahzantive | Formycon AG | Jun 2024 | 761378 | Biosimilar | Approved | S001, S016 |
| FDA | Enzeevu | Sandoz Inc. | Aug 2024 | 761382 | Biosimilar | Approved | S001, S016 |
| FDA | Pavblu | Amgen Inc. | Aug 2024 | 761298 | Biosimilar | Approved | S001, S016 |
| FDA | Eydenzelt | CELLTRION, Inc. | Oct 2025 | 761377 | Biosimilar | Approved | S001, S016 |
| EMA | Yesafili | Biosimilar Collaborations Ireland Limited | Sep 2023 | EMEA/H/C/006022 | Approved | S017 | |
| EMA | Opuviz | Samsung Bioepis NL B.V. | Nov 2024 | EMEA/H/C/006056 | Approved | S017 | |
| EMA | Afqlir | Sandoz GmbH | Nov 2024 | EMEA/H/C/006150 | Approved | S017 | |
| EMA | Ahzantive | Formycon AG | Jan 2025 | EMEA/H/C/006607 | Approved | S017 | |
| EMA | Baiama | Formycon AG | Jan 2025 | EMEA/H/C/005980 | Approved | S017 | |
| EMA | Eydenzelt | Celltrion Healthcare Hungary Kft. | Feb 2025 | EMEA/H/C/005899 | Approved | S017 | |
| EMA | Pavblu | Amgen Technology (Ireland) UC | Apr 2025 | EMEA/H/C/006339 | Approved | S017 | |
| EMA | Eiyzey | Zaklady Farmaceutyczne Polpharma S.A. | Aug 2025 | EMEA/H/C/006745 | Approved | S017 | |
| EMA | Vgenfli | Zaklady Farmaceutyczne Polpharma S.A. | Aug 2025 | EMEA/H/C/006192 | Approved | S017 | |
| EMA | Afiveg | STADA Arzneimittel AG | Aug 2025 | EMEA/H/C/006761 | Approved | S017 | |
| EMA | Mynzepli | Advanz Pharma Limited | Aug 2025 | EMEA/H/C/006438 | Approved | S017 | |
| EMA | Eyluxvi | Biolitec pharma Limited Zweigniederlassung Jena | Sep 2025 | EMEA/H/C/006282 | Approved | S017 | |
| EMA | Skojoy | Amgen Technology (Ireland) UC | not published | EMEA/H/C/006551 | Withdrawn | S017 | |
| MHRA | Afqlir | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ahzantive | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Eydenzelt | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Mynzepli | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Opuviz | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Pavblu | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Vgenfli | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Yesafili | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Aflibercept BS GRP | Global Regulatory Partners | Jun 2024 | not published | Approved | S020 | |
| PMDA | Aflibercept BS NIT | Fuji Pharma | Sep 2025 | not published | Approved | S020 | |
| PMDA | Aflibercept BS SCD | SamChunDang Pharm | Sep 2025 | not published | Approved | S020 | |
| PMDA | Aflibercept BS CT | Celltrion Healthcare Japan | Mar 2026 | not published | Approved | S020 | |
| HC | Aflivu | Apotex INC | Jun 2025 | DIN 02554178, 02554194 | Approved | S022 | |
| HC | Yesafili | Biocon Biologics Canada INC | Jun 2025 | DIN 02535858, 02558238 | Approved | S022 | |
| HC | Pavblu | Amgen Canada INC | Jul 2025 | DIN 02550636 | Approved | S022 | |
| HC | Enzeevu | Sandoz Canada Incorporated | Oct 2025 | DIN 02562510 | Approved | S022 | |
| HC | Eydenzelt | Celltrion INC. | Nov 2025 | DIN 02563037, 02563045 | Approved | S022 | |
| CDSCO | Zydus Lifesciences (INN only) | Zydus Lifesciences Limited | Jun 2025 | MF/BIO/25/000092 | Approved | S011 | |
| CDSCO | Yesafili | Biocon Biologics Limited | Sep 2025 | IMP/BIO/25/000112 | Approved | S012 |
Last checked Sep 2026. US interchangeability designations are listed in full on the interchangeable biosimilars page. CDSCO lists permissions by firm and INN, not brand. PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.
Regulatory pathway by market
Requirements for an aflibercept biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | MHRA, United Kingdom | PMDA, Japan | Health Canada | CDSCO, India | EDE, UAE | |
|---|---|---|---|---|---|---|---|
| Legal pathway | Section 351(k) of the Public Health Service Act (BPCIA 2009) | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products | UK marketing authorisation from MHRA. EU approvals in force at the end of 2020 became Great Britain licences automatically; new products since 2021 are approved through reliance on EMA or FDA decisions, and from 2024 through the International Recognition Procedure. Northern Ireland follows EU licences | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 | Notice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026) | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging | EU-authorised reference; a non-EEA comparator may be used with bridging data | Reference biologic authorised in the UK, or an EU-authorised version with bridging data | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision | Reference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data | Product licensed in India, or if not, one licensed in an ICH country, with justification | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient | Follows the EU guideline; MHRA's 2021 biosimilar guidance states that a comparative efficacy trial is generally not needed where analytical and pharmacokinetic comparability is shown | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) | Comparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning | Not defined; prescribing by brand, with pharmacist substitution not automatic | No federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019 | Not defined in the guidelines | Not defined |
| Naming | INN plus a four-letter suffix | INN, identical to the reference; brand name and batch recorded for pharmacovigilance | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary name | Non-proprietary name identical to the reference, with brand name and DIN as identifiers | INN with the brand name | Brand name as registered |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares the comparative evidence plan and the regional dossier strategy for aflibercept programmes. Regulatory strategy consulting
Presentations and concentration
All biosimilar presentations are 40 mg/mL, 2 mg in 0.05 mL per dose, in single-use vials or pre-filled syringes. The 114.3 mg/mL (8 mg) presentation exists only for the reference product.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Yesafili MYL-1701P | 2 mg/0.05 mL vial and PFS | see SmPC | 40 mg/mL vial and syringe | · | 2 mg | 40 mg/mL for intravitreal injection | · |
| Opuviz SB15 | 2 mg/0.05 mL vial and PFS | see SmPC | 40 mg/mL vial and syringe | · | · | · | · |
| Ahzantive / Baiama FYB203 | 2 mg/0.05 mL vial | see SmPC | 40 mg/mL vial and syringe | · | · | · | · |
| Enzeevu / Afqlir | 2 mg/0.05 mL vial | see SmPC | 40 mg/mL vial and syringe | · | 2 mg | · | · |
| Pavblu ABP 938 | 2 mg/0.05 mL vial and PFS | see SmPC | 40 mg/mL vial and syringe | · | 2 mg | · | · |
| Eydenzelt CT-P42 | 2 mg/0.05 mL vial | see SmPC | 40 mg/mL vial and syringe | 40 mg/mL solution and kit | 2 mg | · | · |
| Eiyzey / Vgenfli SCD411 | · | see SmPC | 40 mg/mL vial and syringe | 40 mg/mL solution and kit | · | · | · |
| Afiveg / Mynzepli AVT06 | · | see SmPC | 40 mg/mL vial and syringe | · | · | · | · |
| Eyluxvi ALT-L9 | · | see SmPC | · | · | · | · | · |
| Zydus aflibercept | · | · | · | · | · | 40 mg/mL (2 mg/0.05 mL) for intravitreal injection | · |
| Aflibercept BS GRP | · | · | · | 40 mg/mL intravitreal solution | · | · | · |
| Aflibercept BS NIT | · | · | · | 40 mg/mL solution and kit | · | · | · |
| Aflivu | · | · | · | · | 2 mg | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Biocon Biologics (with Mylan / Viatris) | Yesafili | ✓ | ✓ | ✓ | · | ✓ | ✓ | · |
| Samsung Bioepis | Opuviz | ✓ | ✓ | ✓ | · | · | · | · |
| Formycon | Ahzantive / Baiama | ✓ | ✓ | ✓ | · | · | · | · |
| Sandoz | Enzeevu / Afqlir | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Amgen | Pavblu | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Celltrion | Eydenzelt | ✓ | ✓ | ✓ | ✓ | ✓ | · | · |
| Sam Chun Dang Pharm | Eiyzey / Vgenfli | · | ✓ | ✓ | ✓ | · | · | · |
| Alvotech | Afiveg / Mynzepli | · | ✓ | ✓ | · | · | · | · |
| Alteogen | Eyluxvi | · | ✓ | · | · | · | · | · |
| Zydus Lifesciences | Zydus aflibercept | · | · | · | · | · | ✓ | · |
| Global Regulatory Partners | Aflibercept BS GRP | · | · | · | ✓ | · | · | · |
| Fuji Pharma | Aflibercept BS NIT | · | · | · | ✓ | · | · | · |
| Apotex | Aflivu | · | · | · | · | ✓ | · | · |
Entering a market where a competitor is already listed changes the evidence and pricing conversation. EvySaif's global value dossier and HTA submission work covers that side.
Products
Yesafili
Opuviz
Ahzantive / Baiama
Enzeevu / Afqlir
Pavblu
Eydenzelt
Eiyzey / Vgenfli
Afiveg / Mynzepli
Eyluxvi
Zydus aflibercept
Aflibercept BS GRP
Aflibercept BS NIT
Aflivu
In development
ClinicalTrials.gov holds six comparative trials of six aflibercept biosimilar candidates against the reference product, run by five sponsors. Two of the candidates (AVT29, QL1207) have no approval yet in any of the seven markets, so they show where the next competition may come from. Trials are listed with the sponsor's own wording for status and dates.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|
| AVT29 | Alvotech | Eylea | Phase 3 | Comparative efficacy | Recruiting | Apr 2026 | Jul 2027 | no approval in the seven markets | NCT07489131 |
| AVT06 | Alvotech | Eylea | Phase 3 | Comparative efficacy | Completed | Jun 2022 | Nov 2023 | Afiveg / Mynzepli | NCT05155293 |
| FYB203 | Bioeq | Eylea | Phase 3 | Comparative efficacy | Completed | Jul 2020 | Jun 2022 | Ahzantive / Baiama | NCT04522167 |
| QL1207 | Qilu Pharmaceutical | Eylea | Phase 3 | Comparative efficacy | Completed | Aug 2019 | Jan 2022 | no approval in the seven markets | NCT05345236 |
| SCD411 | Sam Chun Dang Pharm | Eylea | Phase 3 | Comparative efficacy | Completed | Aug 2020 | Sep 2022 | Eiyzey / Vgenfli | NCT04480463 |
| SB15 | Samsung Bioepis | Eylea | Phase 3 | Comparative efficacy | Completed | Jun 2020 | Apr 2021 | Opuviz | NCT04450329 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026. The full list across all molecules is on the pipeline page.
Questions
Which was the first aflibercept biosimilar?
In the United States, Biocon's Yesafili and Samsung Bioepis's Opuviz on the same day in May 2024, both interchangeable. In Europe, Yesafili in 2023.
Is there a biosimilar of the higher-dose Eylea?
No. The 8 mg version is a separate product with its own patents and has no biosimilar in any market.
Which aflibercept biosimilars are registered in the UAE?
None yet. Only Eylea and its higher-dose form are registered.
Is there an aflibercept biosimilar in India?
Yes. Zydus received the first domestic permission in 2025, and Biocon's Yesafili was permitted for import the same year.
How is an aflibercept biosimilar tested?
Laboratory comparison and a clinical study measuring sight in patients with wet macular degeneration, with full testing of the syringe.
Are aflibercept biosimilars interchangeable in the United States?
Two of the six are: Yesafili and Opuviz, both designated on the day of approval.
Work with EvySaif on aflibercept
Aflibercept biosimilar landscape report
The register on this page as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, updated to the month, with the sources attached.
Request the landscape reportRegulatory gap assessment
For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects for aflibercept, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)S024ClinicalTrials.gov, study records (API v2, one query per molecule with the term biosimilar) Registry (sponsor-entered)
Planning aflibercept biosimilar development?
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