Bevacizumab biosimilars
An antibody that starves tumours of blood supply, used in bowel, lung, kidney, ovarian and cervical cancers, with Indian biosimilars since 2016.
About bevacizumab
Bevacizumab is an antibody that blocks a growth factor called VEGF, which tumours use to grow new blood vessels. Cutting off that signal slows the tumour's blood supply. It is given alongside chemotherapy in several common cancers.
It works by binding VEGF in the blood before the growth factor can reach the cells lining blood vessels. Unlike some cancer antibodies it does not attach to the tumour cells themselves, which makes it simpler to copy.
It is an infusion into a vein every two or three weeks, from vials of liquid concentrate in two sizes.
Bowel cancer, non-small cell lung cancer, kidney cancer, ovarian cancer, cervical cancer and, in some markets, brain tumours and liver cancer. Each product's licensed uses are in the tables below.
Because bevacizumab acts on a protein in the blood rather than on cells, regulators have accepted a single clinical comparison in lung cancer and extended the approval to all the other cancers. Immune reactions are very rare.
The reference product is Avastin, from Roche. Biosimilars reached Europe and the United States from 2017, though US launches waited until 2019 under a settlement.
Bevacizumab is one of the most widely used cancer antibodies by volume, and one of the easiest to copy because its action does not depend on the antibody's tail. India was first, with Reliance in 2016, and now has seven domestic makers. Several of those Indian products have since been approved in Europe, Japan, Canada and the Gulf.
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
- Today19 bevacizumab biosimilars are approved in at least one of the seven markets.
- With regulators nowEU application 005995, EU application 006944 are under review. A decision usually comes within a year.
- Nearest to marketBCD-021, BP102, HD204, TAB008 have reached phase 3, the last trial before a filing.
- Further outIBI305, RPH-001, SCT510, TRS003 are still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from 19 to 29. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so 27 is the more realistic figure.
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 | Mvasi | Amgen Inc. | Sep 2017 | 761028 | Biosimilar | Approved | S001, S016 |
| FDA | Zirabev | Pfizer Inc. | Jun 2019 | 761099 | Biosimilar | Approved | S001, S016 |
| FDA | Alymsys | Amneal Pharmaceuticals LLC | Apr 2022 | 761231 | Biosimilar | Approved | S001, S016 |
| FDA | Vegzelma | CELLTRION, Inc. | Sep 2022 | 761268 | Biosimilar | Approved | S001, S016 |
| FDA | Avzivi | Bio-Thera Solutions, Ltd. | Dec 2023 | 761198 | Biosimilar | Approved | S001, S016 |
| FDA | Jobevne | Biocon Biologics Inc. | Apr 2025 | 761175 | Biosimilar | Approved | S001, S016 |
| EMA | Mvasi | Amgen Technology (Ireland) UC | Jan 2018 | EMEA/H/C/004728 | Approved | S017 | |
| EMA | Zirabev | Pfizer Europe MA EEIG | Feb 2019 | EMEA/H/C/004697 | Approved | S017 | |
| EMA | Aybintio | Samsung Bioepis NL B.V. | Aug 2020 | EMEA/H/C/005106 | Approved | S017 | |
| EMA | Equidacent | Centus Biotherapeutics Europe Limited | Sep 2020 | EMEA/H/C/005181 | Withdrawn | S017 | |
| EMA | Onbevzi | Samsung Bioepis NL B.V. | Jan 2021 | EMEA/H/C/005640 | Withdrawn | S017 | |
| EMA | Alymsys | Mabxience Research SL | Mar 2021 | EMEA/H/C/005286 | Approved | S017 | |
| EMA | Oyavas | STADA Arzneimittel AG | Mar 2021 | EMEA/H/C/005556 | Approved | S017 | |
| EMA | Abevmy | Biosimilar Collaborations Ireland Limited | Apr 2021 | EMEA/H/C/005327 | Approved | S017 | |
| EMA | Vegzelma | Celltrion Healthcare Hungary Kft. | Aug 2022 | EMEA/H/C/005534 | Approved | S017 | |
| EMA | Avzivi | FGK Representative Service GmbH | Jul 2024 | EMEA/H/C/005574 | Approved | S017 | |
| EMA | Lextemy | Mylan IRE Healthcare Limited | not published | EMEA/H/C/005611 | Withdrawn | S017 | |
| EMA | Application 005995 | Applicant not yet named by EMA | since Dec 2025 | EMEA/H/C/005995 | Under review | S019 | |
| EMA | Application 006944 | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/006944 | Under review | S019 | |
| MHRA | Abevmy | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Alymsys | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Oyavas | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Aybintio | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Vegzelma | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Zirabev | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ankevda | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Bevqolva | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Versavo | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Bevacizumab BS [Pfizer] | Pfizer Japan | Jun 2019 | not published | Approved | S020 | |
| PMDA | Bevacizumab BS Amgen | Amgen K.K. | Sep 2019 | not published | Approved | S020 | |
| PMDA | Bevacizumab BS Nichi-Iko | Nichi-Iko Pharmaceutical | Jan 2022 | not published | Approved | S020 | |
| PMDA | Bevacizumab BS CTNK | Nippon Kayaku (Celltrion) | Sep 2022 | not published | Approved | S020 | |
| HC | Mvasi | Amgen Canada INC | Apr 2018 | DIN 02470748, 02470756 | Approved | S022 | |
| HC | Zirabev | Pfizer Canada ULC | Jun 2019 | DIN 02489430, 02489449 | Approved | S022 | |
| HC | Bambevi | Apotex INC | Sep 2021 | DIN 02520729, 02520737 | Approved | S022 | |
| HC | Abevmy | Biocon Biologics Canada INC | Nov 2021 | DIN 02522160, 02522179 | Approved | S022 | |
| HC | Aybintio | Samsung Bioepis CO., LTD | Nov 2021 | DIN 02522829, 02522837 | Approved | S022 | |
| HC | Vegzelma | Celltrion INC. | Jan 2023 | DIN 02534177, 02534185 | Approved | S022 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Jan 2016 | MF-48/2016 | Approved | S014 | |
| CDSCO | Hetero Drugs (INN only) | Hetero Drugs Limited | May 2016 | MF-63/2016 | Approved | S014 | |
| CDSCO | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals Ltd | Jun 2016 | MF-65/2016 | Approved | S014 | |
| CDSCO | Krabeva | Biocon Limited | May 2017 | MF-90/2017 | Approved | S014 | |
| CDSCO | Cadila Healthcare (INN only) | Cadila Healthcare Ltd | May 2017 | MF-097/2017 | Approved | S014 | |
| CDSCO | Dr. Reddy's Laboratories (INN only) | Dr. Reddy's Laboratories Ltd | Sep 2018 | MF/BIO/18/000025 | Approved | S014 | |
| CDSCO | Enzene Biosciences (INN only) | Enzene Biosciences Ltd | Feb 2023 | MF/BIO/23/000011 | Approved | S011 | |
| CDSCO | CuraTeQ Biologics Private (INN only) | CuraTeQ Biologics Private Limited | May 2026 | MF/BIO/26/000060 | Approved | S011 | |
| EDE | Mvasi | Amgen Technology (Ireland) Unlimited Company | Apr 2020 | not published | Registered | S018 | |
| EDE | Zirabev | Pfizer Service Company BVBA, Belgium | Dec 2020 | not published | Registered | S018 | |
| EDE | Abevmy | Biocon Biologics Limited, India | Feb 2022 | 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 bevacizumab 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 bevacizumab programmes. Regulatory strategy consulting
Presentations and concentration
All presentations are 25 mg/mL concentrate for infusion; 100 mg in 4 mL and 400 mg in 16 mL single-use vials.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Mvasi ABP 215 | 100 mg/4 mL, 400 mg/16 mL | see SmPC | · | 100 mg and 400 mg vials | 25 mg | · | 100 mg/4 mL, 400 mg/16 mL |
| Zirabev PF-06439535 | 100 mg/4 mL, 400 mg/16 mL | see SmPC | 100 mg/4 mL and 400 mg/16 mL vials | 100 mg and 400 mg vials | 100, 400 mg | · | 100 mg/4 mL, 400 mg/16 mL |
| Alymsys / Oyavas MB02 | 100 mg/4 mL, 400 mg/16 mL | see SmPC | 25 mg/mL vials | · | · | · | · |
| Vegzelma CT-P16 | 100 mg/4 mL, 400 mg/16 mL | see SmPC | 25 mg/mL vials | 100 mg and 400 mg vials | 100, 400 mg | · | · |
| Avzivi BAT1706 | 100 mg/4 mL, 400 mg/16 mL | see SmPC | · | · | · | · | · |
| Jobevne / Abevmy / Krabeva Bmab-100 | 100 mg/4 mL, 400 mg/16 mL | see SmPC | 25 mg/mL vials | · | 100, 400 mg | 100 mg/4 mL and 400 mg/16 mL | 400 mg vial (Feb 2022); 100 mg vial (Jun 2022) |
| Aybintio SB8 | · | see SmPC | 25 mg/mL vials | · | 100, 400 mg | · | · |
| Equidacent FKB238 | · | see SmPC | · | · | · | · | · |
| Lextemy | · | see SmPC | · | · | · | · | · |
| Reliance Life Sciences bevacizumab | · | · | · | · | · | 100 mg/4 mL and 400 mg/16 mL | · |
| Hetero bevacizumab | · | · | · | · | · | 100 mg/4 mL and 400 mg/16 mL | · |
| Intas bevacizumab | · | · | · | · | · | 100 mg/4 mL and 400 mg/16 mL | · |
| Zydus bevacizumab | · | · | · | · | · | 100 mg/4 mL and 400 mg/16 mL | · |
| Dr. Reddy's bevacizumab | · | · | · | · | · | 100 mg/4 mL and 400 mg/16 mL | · |
| Enzene Biosciences bevacizumab | · | · | · | · | · | 100 mg/4 mL and 400 mg/16 mL | · |
| CuraTeQ bevacizumab | · | · | · | · | · | 100 mg/4 mL and 400 mg/16 mL | · |
| EU application 005995 | · | see SmPC | · | · | · | · | · |
| EU application 006944 | · | see SmPC | · | · | · | · | · |
| Bevacizumab BS Nichi-Iko | · | · | · | 100 mg and 400 mg vials | · | · | · |
| Bambevi | · | · | · | · | 100, 400 mg | · | · |
| Ankevda | · | · | 25 mg/mL vials | · | · | · | · |
| Bevqolva | · | · | 25 mg/mL vials | · | · | · | · |
| Versavo | · | · | 25 mg/mL vials | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
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
Mvasi
Zirabev
Alymsys / Oyavas
Vegzelma
Avzivi
Jobevne / Abevmy / Krabeva
Aybintio
Equidacent
Lextemy
Reliance Life Sciences bevacizumab
Hetero bevacizumab
Intas bevacizumab
Zydus bevacizumab
Dr. Reddy's bevacizumab
Enzene Biosciences bevacizumab
CuraTeQ bevacizumab
EU application 005995
EU application 006944
Bevacizumab BS Nichi-Iko
Bambevi
Ankevda
Bevqolva
Versavo
In development
ClinicalTrials.gov holds nineteen comparative trials of thirteen bevacizumab biosimilar candidates against the reference product, run by twelve sponsors. Eight of the candidates (BCD-021, BP102, HD204, IBI305, RPH-001, SCT510, TAB008, TRS003) 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 |
|---|---|---|---|---|---|---|---|---|---|
| TAB008 | BioDlink | Avastin | Phase 3 | Comparative efficacy | Completed | Oct 2017 | Mar 2020 | no approval in the seven markets | NCT05427305 |
| BCD-021 | Biocad | Avastin | Phase 3 | Comparative efficacy | Completed | Oct 2012 | Nov 2014 | no approval in the seven markets | NCT01763645 |
| CT-P16 | Celltrion | Avastin | Phase 1 | Comparative PK | Completed | Aug 2017 | Dec 2017 | Vegzelma | NCT03247673 |
| BP102 | Hengrui | Avastin | Phase 3 | Comparative efficacy | Completed | Jan 2018 | Oct 2019 | no approval in the seven markets | NCT05169801 |
| IBI305 | Innovent | Avastin | Phase 1 | Comparative PK | Completed | Mar 2017 | Aug 2017 | no approval in the seven markets | NCT03083990 |
| PF-06439535 | Pfizer | Avastin | Phase 1 | Comparative PK | Completed | Jan 2014 | Aug 2014 | Zirabev | NCT02031991 |
| PF-06439535 | Pfizer | Avastin (as licensed reference) | Phase 1 | Comparative PK | Withdrawn | Jan 2021 | Jul 2021 | Zirabev | NCT04126044 |
| HD204 | Prestige Biopharma | Avastin | Phase 3 | Comparative efficacy | Active, not recruiting | Nov 2019 | Jul 2024 | no approval in the seven markets | NCT03390686 |
| SB8 | Samsung Bioepis | Avastin | Phase 1 | Comparative PK | Completed | Apr 2015 | Sep 2015 | Aybintio | NCT02453672 |
| SB8 | Samsung Bioepis | Avastin | Phase 3 | Comparative efficacy | Completed | Jul 2016 | Jan 2018 | Aybintio | NCT02754882 |
| SCT510 | Sinocelltech (hospital sponsor) | Avastin | Phase 1 | Comparative PK | Completed | May 2018 | Nov 2018 | no approval in the seven markets | NCT05113511 |
| RPH-001 | TRPharm | Avastin | Phase 1 | Comparative PK | Withdrawn | Dec 2017 | Jan 2018 | no approval in the seven markets | NCT03131700 |
| TRS003 | Teruisi | Avastin | Phase 1 | Comparative PK | Completed | Jun 2018 | Sep 2018 | no approval in the seven markets | NCT03882424 |
| MB02 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Aug 2019 | Dec 2019 | Alymsys / Oyavas | NCT04238650 |
| MB02 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Dec 2017 | May 2019 | Alymsys / Oyavas | NCT03293654 |
| MB02 | mAbxience | Avastin | Phase 3 | Comparative efficacy | Completed | Feb 2018 | Jul 2019 | Alymsys / Oyavas | NCT03296163 |
| MB02 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Jan 2021 | Aug 2021 | Alymsys / Oyavas | NCT04408989 |
| BEVZ92 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Oct 2014 | Oct 2015 | Alymsys / Oyavas | NCT02069704 |
| MB02 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Sep 2019 | Mar 2020 | Alymsys / Oyavas | NCT04238663 |
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 bevacizumab biosimilar?
Reliance Life Sciences in India, in 2016. The first in Europe and the United States, Amgen's Mvasi, came the following year.
How is a bevacizumab biosimilar tested?
Laboratory comparison, a study in healthy volunteers, and a clinical comparison in lung cancer, which regulators accept as covering the other cancers too.
Are bevacizumab biosimilars interchangeable in the United States?
No. None carries the designation, which matters little for a hospital-infused drug.
Which bevacizumab biosimilars are registered in the UAE?
Products from Amgen, Pfizer and Biocon, alongside Avastin.
Why are there so many Indian bevacizumab biosimilars?
The cancers it treats are common, the antibody is comparatively simple to make, and the reference product was costly. Seven Indian companies hold permissions.
Does any biosimilar cover liver cancer?
In India, some products have been permitted for liver cancer in combination with another antibody. Elsewhere, biosimilar labels follow the reference product at the time of approval.
Work with EvySaif on bevacizumab
Bevacizumab 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 bevacizumab, 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)S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 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 bevacizumab biosimilar development?
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