Trastuzumab biosimilars
An antibody for HER2-positive breast and stomach cancer, and the first cancer antibody to have biosimilars, starting in India in 2013.
About trastuzumab
Trastuzumab is an antibody that targets HER2, a protein found in large amounts on the surface of some breast and stomach cancer cells. It was the first antibody approved for a solid tumour and changed the outlook for HER2-positive breast cancer.
It attaches to HER2 on the cancer cell and blocks the growth signals the protein sends. It also marks the cell so the immune system attacks it. That second action depends on the tail of the antibody, which is why biosimilar makers have to match that part of the molecule closely.
It is given as an infusion into a vein, usually every three weeks, from vials of powder that are made up before use. The original product also exists as an injection under the skin, but no biosimilar of that form has been approved.
HER2-positive breast cancer, both early and advanced, and HER2-positive stomach cancer. Indications for each product are in the tables below.
Regulators compare a trastuzumab biosimilar mainly in the laboratory, especially the part of the antibody that recruits immune cells. A clinical comparison is usually done in women treated before breast surgery, where the effect can be measured within months by how much of the tumour disappears.
The reference product is Herceptin, from Roche. Its patents expired in Europe in 2014 and in the United States in 2019, and biosimilars followed in each market soon after. It remains one of the most widely used cancer antibodies.
Trastuzumab opened the door for cancer biosimilars. India was first: Biocon's product was approved in 2013, four years before Europe or the United States. Several Indian companies now make it, and the same Indian products have gone on to approval 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
- Todaythirteen trastuzumab biosimilars are approved in at least one of the seven markets.
- Nearest to marketAryoTrust, SIBP-01 have reached phase 3, the last trial before a filing.
- Further outALT02, CTTQ trastuzumab, Incepta trastuzumab are still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from thirteen to eighteen.
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 | Ogivri | Biocon Biologics Inc. | Dec 2017 | 761074 | Biosimilar | Approved | S001, S016 |
| FDA | Herzuma | CELLTRION, Inc. | Dec 2018 | 761091 | Biosimilar | Approved | S001, S016 |
| FDA | Ontruzant | Samsung Bioepis Co., Ltd. | Jan 2019 | 761100 | Biosimilar | Approved | S001, S016 |
| FDA | Trazimera | Pfizer Ireland Pharmaceuticals Unlimited Company | Mar 2019 | 761081 | Biosimilar | Approved | S001, S016 |
| FDA | Kanjinti | Amgen Inc. | Jun 2019 | 761073 | Biosimilar | Approved | S001, S016 |
| FDA | Hercessi | Accord BioPharma Inc. | Apr 2024 | 761346 | Biosimilar | Approved | S001, S016 |
| EMA | Ontruzant | Samsung Bioepis NL B.V. | Nov 2017 | EMEA/H/C/004323 | Approved | S017 | |
| EMA | Herzuma | Celltrion Healthcare Hungary Kft. | Feb 2018 | EMEA/H/C/002575 | Approved | S017 | |
| EMA | Kanjinti | Amgen Europe B.V. | May 2018 | EMEA/H/C/004361 | Approved | S017 | |
| EMA | Trazimera | Pfizer Europe MA EEIG | Jul 2018 | EMEA/H/C/004463 | Approved | S017 | |
| EMA | Ogivri | Biosimilar Collaborations Ireland Limited | Dec 2018 | EMEA/H/C/004916 | Approved | S017 | |
| EMA | Zercepac | Accord Healthcare S.L.U. | Jul 2020 | EMEA/H/C/005209 | Approved | S017 | |
| EMA | Herwenda | Sandoz GmbH | Nov 2023 | EMEA/H/C/005769 | Approved | S017 | |
| EMA | Dazublys | CuraTeQ Biologics (Malta) Limited | Jun 2025 | EMEA/H/C/006219 | Approved | S017 | |
| EMA | Tuznue | Prestige Biopharma Belgium | not published | EMEA/H/C/005066 | Withdrawn | S017 | |
| EMA | Hervelous | Prestige Biopharma Belgium | not published | EMEA/H/C/005880 | Withdrawn | S017 | |
| MHRA | Dazublys | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Herzuma | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ogivri | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ontruzant | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Trazimera | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Zercepac | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Trastuzumab BS NK | Celltrion Healthcare Japan (marketed by Nippon Kayaku) | Mar 2018 | not published | Approved | S020 | |
| PMDA | Trastuzumab BS Daiichi Sankyo | Daiichi Sankyo | Sep 2018 | not published | Approved | S020 | |
| PMDA | Trastuzumab BS [Pfizer] | Pfizer Japan | Sep 2018 | not published | Approved | S020 | |
| HC | Ogivri | Biosimilar Collaborations Ireland Limited | May 2019 | DIN 02474425, 02474433 | Approved | S022 | |
| HC | Trazimera | Pfizer Canada ULC | Aug 2019 | DIN 02483467, 02483475 | Approved | S022 | |
| HC | Herzuma | Celltrion INC. | Sep 2019 | DIN 02480794, 02506211 | Approved | S022 | |
| HC | Kanjinti | Amgen Canada INC | Feb 2020 | DIN 02496690, 02518244 | Approved | S022 | |
| HC | Ontruzant | Samsung Bioepis CO., LTD | Jan 2022 | DIN 02524317, 02524325 | Approved | S022 | |
| CDSCO | CANMAb | Biocon Limited | Oct 2013 | MF-241/2013 | Approved | S014 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Jun 2015 | MF-120/2015 | Approved | S014 | |
| CDSCO | Cadila Healthcare (INN only) | Cadila Healthcare Ltd | Oct 2015 | MF-209/2015 | Approved | S014 | |
| CDSCO | Dr. Reddy's Laboratories (INN only) | Dr. Reddy's Laboratories Ltd | Mar 2018 | MF-69/2018 | Approved | S014 | |
| CDSCO | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals Ltd | Apr 2018 | MF-119/2018 | Approved | S014 | |
| CDSCO | Biocad India (INN only) | Biocad India Pvt Ltd | Apr 2018 | Import permission | Approved | S013 | |
| CDSCO | CuraTeQ Biologics Private (INN only) | CuraTeQ Biologics Private Limited | Mar 2024 | MF/BIO/24/000036 | Approved | S011 | |
| CDSCO | Biocon Biologics (INN only) | Biocon Biologics Limited | Nov 2025 | MF/BIO/25/000156 | Approved | S011 | |
| EDE | Ogivri | Biocon Biologics Limited, India | Nov 2018 | not published | Registered | S018 | |
| EDE | Kanjinti | Amgen Europe B.V. | Feb 2019 | not published | Registered | S018 | |
| EDE | Herzuma | Hikma Pharmaceuticals, Jordan (for Celltrion) | Apr 2020 | not published | Registered | S018 | |
| EDE | Trazimera | Pfizer Manufacturing Belgium NV | Apr 2020 | 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 trastuzumab 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 trastuzumab programmes. Regulatory strategy consulting
Presentations and concentration
Lyophilised vials; 150 mg single-dose and 420 mg or 440 mg multi-dose. The 440 mg presentation is the original multi-dose vial, the 420 mg the later one.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Kanjinti ABP 980 | 150 mg, 420 mg vials | see SmPC | · | 60 mg and 150 mg vials | 150, 420 mg | · | 150 mg and 420 mg vials |
| Herzuma CT-P6 | 150 mg, 420 mg vials | see SmPC | 150 mg and 420 mg vials | 60 mg and 150 mg vials | 150, 440 mg | · | 150 mg and 440 mg vials |
| Ontruzant SB3 | 150 mg, 420 mg vials | see SmPC | 150 mg vial | · | 150, 440 mg | · | · |
| Trazimera PF-05280014 | 150 mg, 420 mg vials | see SmPC | 150 mg and 420 mg vials | 60 mg and 150 mg vials | 150, 440 mg | · | 150 mg and 440 mg vials |
| Ogivri / CANMAb MYL-1401O (Bmab-200) | 150 mg, 420 mg vials | see SmPC | 150 mg and 420 mg vials | · | 150, 440 mg | 150 mg single-use and 440 mg multi-use vials; 150 mg and 440 mg multi-use vials, combipack with bacteriostatic water | 440 mg vial |
| Hercessi / Zercepac HLX02 | 150 mg, 420 mg vials | see SmPC | 60 mg, 150 mg and 420 mg vials | · | · | · | · |
| Herwenda EG12014 | · | see SmPC | · | · | · | · | · |
| Dazublys / CuraTeQ trastuzumab | · | see SmPC | 150 mg vial | · | · | 150 mg and 420 mg vials | · |
| Tuznue / Hervelous HD201 | · | see SmPC | · | · | · | · | · |
| Reliance Life Sciences trastuzumab | · | · | · | · | · | 150 mg and 440 mg vials | · |
| Zydus trastuzumab | · | · | · | · | · | 150 mg single-use and 440 mg multi-use vials | · |
| Dr. Reddy's trastuzumab | · | · | · | · | · | 150 mg and 440 mg vials | · |
| Intas trastuzumab | · | · | · | · | · | 150 mg and 440 mg vials | · |
| Biocad trastuzumab BCD-022 | · | · | · | · | · | 150 mg single-use and 440 mg multi-use vials | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Amgen | Kanjinti | ✓ | ✓ | · | ✓ | ✓ | · | ✓ |
| Celltrion | Herzuma | ✓ | ✓ | ✓ | ✓ | ✓ | · | ✓ |
| Samsung Bioepis | Ontruzant | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Pfizer | Trazimera | ✓ | ✓ | ✓ | ✓ | ✓ | · | ✓ |
| Biocon Biologics (with Mylan / Viatris) | Ogivri / CANMAb | ✓ | ✓ | ✓ | · | ✓ | ✓ | ✓ |
| Shanghai Henlius Biotech | Hercessi / Zercepac | ✓ | ✓ | ✓ | · | · | · | · |
| EirGenix | Herwenda | · | ✓ | · | · | · | · | · |
| CuraTeQ Biologics (Aurobindo) | Dazublys / CuraTeQ trastuzumab | · | ✓ | ✓ | · | · | ✓ | · |
| Prestige Biopharma | Tuznue / Hervelous | · | withdrawn | · | · | · | · | · |
| Reliance Life Sciences | Reliance Life Sciences trastuzumab | · | · | · | · | · | ✓ | · |
| Cadila Healthcare (Zydus Lifesciences) | Zydus trastuzumab | · | · | · | · | · | ✓ | · |
| Dr. Reddy's Laboratories | Dr. Reddy's trastuzumab | · | · | · | · | · | ✓ | · |
| Intas Pharmaceuticals | Intas trastuzumab | · | · | · | · | · | ✓ | · |
| Biocad | Biocad trastuzumab | · | · | · | · | · | ✓ | · |
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
Kanjinti
Herzuma
Ontruzant
Trazimera
Ogivri / CANMAb
Hercessi / Zercepac
Herwenda
Dazublys / CuraTeQ trastuzumab
Tuznue / Hervelous
Reliance Life Sciences trastuzumab
Zydus trastuzumab
Dr. Reddy's trastuzumab
Intas trastuzumab
Biocad trastuzumab
In development
ClinicalTrials.gov holds nine comparative trials of nine trastuzumab biosimilar candidates against the reference product, run by nine sponsors. Five of the candidates (ALT02, AryoTrust, CTTQ trastuzumab, Incepta trastuzumab, SIBP-01) 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 |
|---|---|---|---|---|---|---|---|---|---|
| ALT02 | Alteogen | Herceptin | Phase 1 | Comparative PK | Completed | Feb 2016 | Aug 2016 | no approval in the seven markets | NCT03242239 |
| AryoTrust | AryoGen Pharmed | Herceptin | Phase 3 | Comparative efficacy | Completed | Jul 2016 | Mar 2018 | no approval in the seven markets | NCT03425656 |
| BCD-022 | Biocad | Herceptin | Phase 3 | Comparative efficacy | Completed | Oct 2012 | Mar 2015 | Biocad trastuzumab | NCT01764022 |
| CTTQ trastuzumab | Chia Tai Tianqing | Herceptin | Phase 1 | Comparative PK | Completed | Jul 2017 | Oct 2017 | no approval in the seven markets | NCT05765357 |
| Incepta trastuzumab | Incepta Pharmaceuticals | Herceptin (as licensed reference) | Phase 1 | Comparative PK | Completed | Jan 2024 | Dec 2024 | no approval in the seven markets | NCT06886659 |
| HD201 | Prestige Biopharma | Herceptin | Phase 3 | Comparative efficacy | Completed | Feb 2018 | Apr 2019 | Tuznue / Hervelous | NCT03013504 |
| SB3 | Samsung Bioepis | Herceptin | Phase 3 | Comparative efficacy | Completed | Apr 2014 | Mar 2016 | Ontruzant | NCT02149524 |
| HLX02 | Shanghai Henlius Biotech | Herceptin | Phase 3 | Comparative efficacy | Completed | Nov 2016 | Nov 2018 | Hercessi / Zercepac | NCT03084237 |
| SIBP-01 | Shanghai Institute of Biological Products | Herceptin | Phase 3 | Comparative efficacy | Completed | Jun 2019 | Apr 2023 | no approval in the seven markets | NCT03989037 |
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 trastuzumab biosimilar?
Biocon's product, sold in India as CANMAb, approved in 2013. Europe and the United States approved their first in 2017.
Is there a trastuzumab biosimilar given under the skin?
No. All approved biosimilars are infusions. The under-the-skin version of Herceptin is a separate product with its own patents.
How is a trastuzumab biosimilar tested?
Mainly in the laboratory, where the part of the antibody that calls in immune cells is compared closely, plus a study in healthy volunteers and a clinical comparison in early breast cancer.
Why does India have so many trastuzumab biosimilars?
Breast cancer is common, the originator was expensive, and Indian companies had the antibody manufacturing capacity. Six domestic makers hold permissions.
Which trastuzumab biosimilars are registered in the UAE?
Four, from Amgen, Celltrion, Pfizer and Biocon, alongside Herceptin.
Are trastuzumab biosimilars interchangeable in the United States?
No. None of the six FDA-approved products carries the interchangeable designation, though this is less important for a hospital-infused cancer drug than for a self-injected one.
Work with EvySaif on trastuzumab
Trastuzumab 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 trastuzumab, 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)S013CDSCO, import and market permissions till 2019 (r-DNA) 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)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)
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