Ranibizumab biosimilars
An eye injection for wet macular degeneration and diabetic eye disease, first copied in India in 2015, six years before anywhere else.
About ranibizumab
Ranibizumab is a small fragment of an antibody, designed to be injected into the eye. It blocks VEGF, the growth factor that causes abnormal, leaky blood vessels to form at the back of the eye in wet macular degeneration and diabetic eye disease.
The abnormal vessels leak fluid and blood into the retina and damage sight. Blocking VEGF stops the vessels growing and leaking, and in many patients sight improves.
A very small injection into the eye, usually monthly to begin with and then less often, from a vial or a pre-filled syringe. The syringe and the injection procedure are part of what regulators assess.
Wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy, retinal vein occlusion and other causes of abnormal blood vessels in the eye.
Because so little of the drug reaches the bloodstream, a biosimilar is compared by its effect on sight in patients with macular degeneration over a couple of months, alongside detailed laboratory comparison. Immune reactions have not been a problem.
The reference product is Lucentis, from Roche in the United States and Novartis elsewhere. Biosimilars reached Europe and the United States in 2021.
India led the world on ranibizumab by six years. Intas's Razumab was approved in 2015, six years before the first biosimilar anywhere else. Indian companies now supply the United States and Europe: Zydus, Lupin and Intas all hold Western approvals for products first permitted at home. The clinical programme is short and inexpensive; the difficulty is the sterile syringe.
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
- Todayfifteen ranibizumab biosimilars are approved in at least one of the seven markets.
- Nearest to marketCKD-701, Incepta ranibizumab have reached phase 3, the last trial before a filing.
- Further outPF582 is still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from fifteen to eighteen.
2 published switching studies with ranibizumab biosimilars, and where evidence is still missing.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| FDA | Byooviz | Samsung Bioepis Co., Ltd. | Sep 2021 | 761202 | Interchangeable | Approved | S001, S016 |
| FDA | Cimerli | Sandoz Inc. | Aug 2022 | 761165 | Interchangeable | Approved | S001, S016 |
| FDA | Nufymco | Zydus Lifesciences Global FZE | Dec 2025 | 761473 | Interchangeable | Approved | S001, S016 |
| FDA | Ranluspec | Lupin Limited (Biotech Division) | Jun 2026 | 761480 | Interchangeable | Approved | S001, S016 |
| EMA | Byooviz | Samsung Bioepis NL B.V. | Aug 2021 | EMEA/H/C/005545 | Approved | S017 | |
| EMA | Ranivisio | Midas Pharma GmbH | Aug 2022 | EMEA/H/C/005019 | Approved | S017 | |
| EMA | Ximluci | STADA Arzneimittel AG | Nov 2022 | EMEA/H/C/005617 | Approved | S017 | |
| EMA | Rimmyrah | Qilu Pharma Spain S.L. | Jan 2024 | EMEA/H/C/006055 | Approved | S017 | |
| EMA | Epruvy | Midas Pharma GmbH | Sep 2024 | EMEA/H/C/006528 | Approved | S017 | |
| EMA | Ranluspec | Lupin Europe GmbH | Feb 2026 | EMEA/H/C/006502 | Approved | S017 | |
| EMA | Rexatilux | Intas Third Party Sales 2005 S.L. | Jun 2026 | EMEA/H/C/006634 | Approved | S017 | |
| EMA | Vislyfa | Lupin Europe GmbH | Jul 2026 | EMEA/H/C/006926 | Approved | S017 | |
| MHRA | Byooviz | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ranluspec | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Rimmyrah | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ximluci | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Fovlussea | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ongavia | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Ranibizumab BS Senju | Senju Pharmaceutical | Sep 2021 | not published | Approved | S020 | |
| HC | Melvizo | Samsung Bioepis CO., LTD | Mar 2022 | DIN 02525852 | Approved | S022 | |
| HC | Ranopto | Teva Canada Limited | Oct 2023 | DIN 02542250 | Approved | S022 | |
| CDSCO | Razumab | Intas Pharmaceuticals Ltd | Feb 2015 | MF-35/2015 | Approved | S014 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Mar 2020 | MF/BIO/20/000024 | Approved | S011 | |
| CDSCO | Lupin (INN only) | Lupin Limited | Oct 2021 | MF/BIO/21/000119 | Approved | S011 | |
| CDSCO | Sun Pharmaceutical Industries (INN only) | Sun Pharmaceutical Industries Limited | Mar 2023 | MF/BIO/23/000020 | Approved | S011 | |
| CDSCO | Enzene Biosciences (INN only) | Enzene Biosciences Ltd | Aug 2023 | MF/BIO/23/000080 | Approved | S011 | |
| CDSCO | Zenotech Laboratories (INN only) | Zenotech Laboratories Limited | Oct 2023 | MF/BIO/23/000089 | Approved | S011 | |
| EDE | Ximluci | STADA Arzneimittel AG, Germany | Dec 2023 | not published | Registered | S018 |
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 a ranibizumab 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 ranibizumab programmes. Regulatory strategy consulting
Presentations and concentration
10 mg/mL solution for intravitreal injection, 0.5 mg in 0.05 mL per dose, in single-use vials with filter needle or pre-filled syringes. A 6 mg/mL presentation (0.3 mg dose) exists in the United States.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Byooviz SB11 | 10 mg/mL vial | see SmPC | 10 mg/mL vial and syringe | · | 10 mg | · | · |
| Cimerli / Ranivisio FYB201 | 10 mg/mL and 6 mg/mL vials | see SmPC | · | · | · | · | · |
| Ximluci Xlucane | · | see SmPC | 10 mg/mL vial | · | · | · | 10 mg/mL |
| Rimmyrah QL1205 | · | see SmPC | 10 mg/mL vial and syringe | · | · | · | · |
| Ranluspec / Vislyfa | 10 mg/mL and 6 mg/mL | see SmPC | 10 mg/mL vial and syringe | · | · | 10 mg/mL vial | · |
| Nufymco | 10 mg/mL and 6 mg/mL | · | · | · | · | · | · |
| Rexatilux / Razumab | · | see SmPC | · | · | · | 2.3 mg/0.23 mL single-use vial (10 mg/mL) | · |
| Reliance Life Sciences ranibizumab | · | · | · | · | · | 2.3 mg/0.23 mL and 1.38 mg/0.23 mL vials | · |
| Sun Pharma ranibizumab | · | · | · | · | · | 10 mg/mL single-use vial | · |
| Enzene Biosciences ranibizumab | · | · | · | · | · | 10 mg/mL vial | · |
| Zenotech ranibizumab | · | · | · | · | · | 10 mg/mL single-use vial | · |
| Ranibizumab BS Senju | · | · | · | 10 mg/mL intravitreal kit | · | · | · |
| Ranopto | · | · | · | · | 10 mg | · | · |
| Fovlussea | · | · | 10 mg/mL vial and syringe | · | · | · | · |
| Ongavia | · | · | 10 mg/mL vial and syringe | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Samsung Bioepis | Byooviz | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Bioeq (Formycon and Polpharma) | Cimerli / Ranivisio | ✓ | ✓ | · | · | · | · | · |
| Xbrane Biopharma | Ximluci | · | ✓ | ✓ | · | · | · | ✓ |
| Qilu Pharmaceutical | Rimmyrah | · | ✓ | ✓ | · | · | · | · |
| Lupin | Ranluspec / Vislyfa | ✓ | ✓ | ✓ | · | · | ✓ | · |
| Zydus Lifesciences | Nufymco | ✓ | · | · | · | · | · | · |
| Intas Pharmaceuticals | Rexatilux / Razumab | · | ✓ | · | · | · | ✓ | · |
| Reliance Life Sciences | Reliance Life Sciences ranibizumab | · | · | · | · | · | ✓ | · |
| Sun Pharmaceutical Industries | Sun Pharma ranibizumab | · | · | · | · | · | ✓ | · |
| Enzene Biosciences (Alkem) | Enzene Biosciences ranibizumab | · | · | · | · | · | ✓ | · |
| Zenotech Laboratories | Zenotech ranibizumab | · | · | · | · | · | ✓ | · |
| Senju Pharmaceutical | Ranibizumab BS Senju | · | · | · | ✓ | · | · | · |
| Teva Canada | Ranopto | · | · | · | · | ✓ | · | · |
| Not stated in the MHRA list | Fovlussea | · | · | ✓ | · | · | · | · |
| Not stated in the MHRA list | Ongavia | · | · | ✓ | · | · | · | · |
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
Byooviz
Cimerli / Ranivisio
Ximluci
Rimmyrah
Ranluspec / Vislyfa
Nufymco
Rexatilux / Razumab
Reliance Life Sciences ranibizumab
Sun Pharma ranibizumab
Enzene Biosciences ranibizumab
Zenotech ranibizumab
Ranibizumab BS Senju
Ranopto
Fovlussea
Ongavia
In development
ClinicalTrials.gov holds seven comparative trials of seven ranibizumab biosimilar candidates against the reference product, run by seven sponsors. Three of the candidates (CKD-701, Incepta ranibizumab, PF582) 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 |
|---|---|---|---|---|---|---|---|---|---|
| FYB201 | Bioeq | Lucentis | Phase 3 | Comparative efficacy | Completed | Dec 2015 | Dec 2017 | Cimerli / Ranivisio | NCT02611778 |
| CKD-701 | Chong Kun Dang | Lucentis | Phase 3 | Comparative efficacy | Completed | Oct 2018 | Mar 2021 | no approval in the seven markets | NCT04857177 |
| Incepta ranibizumab | Incepta Pharmaceuticals | Lucentis | Phase 3 | Comparative efficacy | Recruiting | Mar 2024 | Oct 2025 | no approval in the seven markets | NCT06305416 |
| LUBT010 | Lupin | Lucentis | Phase 3 | Comparative efficacy | Completed | Sep 2020 | May 2024 | Ranluspec / Vislyfa | NCT04690556 |
| PF582 | Pfenex | Lucentis | Phase 1/2 | Comparative PK | Completed | Nov 2013 | Jan 2016 | no approval in the seven markets | NCT02121353 |
| SB11 | Samsung Bioepis | Lucentis | Phase 3 | Comparative efficacy | Completed | Mar 2018 | May 2019 | Byooviz | NCT03150589 |
| Xlucane | Xbrane Biopharma | Lucentis | Phase 3 | Comparative efficacy | Completed | Apr 2019 | May 2021 | Ximluci | NCT03805100 |
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 ranibizumab biosimilar in the world?
Intas's Razumab, permitted in India in 2015. Europe and the United States approved their first, Byooviz, in 2021.
Are ranibizumab biosimilars interchangeable in the United States?
Yes, all four, including the two from Indian companies Zydus and Lupin.
How is a ranibizumab biosimilar tested?
By laboratory comparison and a clinical study measuring sight in patients with wet macular degeneration, together with full testing of the syringe.
Which ranibizumab biosimilars are registered in the UAE?
Stada's Ximluci, alongside Lucentis.
Why is the syringe so important?
The drug is injected into the eye, so the syringe must deliver an exact tiny dose and be sterile. Regulators test the device as thoroughly as the drug.
Which Indian companies make ranibizumab?
Intas, Reliance, Lupin, Sun Pharma, Enzene and Zenotech hold permissions.
Work with EvySaif on ranibizumab
Ranibizumab 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 ranibizumab, 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)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory 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)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 ranibizumab biosimilar development?
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