Pertuzumab biosimilars
An antibody used with trastuzumab in HER2-positive breast cancer, with the first Western biosimilar in 2025 and three Indian makers since 2024.
About pertuzumab
Pertuzumab is an antibody that targets HER2, the same protein as trastuzumab, but at a different spot. Given together, the two antibodies block HER2 more completely than either alone, and the combination is standard treatment for HER2-positive breast cancer.
HER2 signals partly by pairing with related receptors on the cell surface. Pertuzumab blocks that pairing, which trastuzumab does not. Like trastuzumab, it also calls in immune cells to attack the tumour.
An infusion into a vein every three weeks, always alongside trastuzumab and chemotherapy, from a single-size vial.
HER2-positive breast cancer, both before surgery and in advanced disease.
A biosimilar is compared in the laboratory, in healthy volunteers, and in a clinical study in women treated before breast surgery, the same design used for trastuzumab biosimilars.
The reference product is Perjeta, from Roche. Roche also sells a combination of pertuzumab and trastuzumab in a single under-the-skin injection, which has no biosimilar and is its main defence.
Companies that have made a trastuzumab biosimilar usually look at pertuzumab next, because the two are given together. India moved first again, with Zydus in 2024 and Intas and Enzene in 2025, against a single Western product from Henlius approved in 2025 and 2026.
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
- Todayfour pertuzumab biosimilars are approved in at least one of the seven markets.
- With regulators nowEU application 006844, EU application 006893 are under review. A decision usually comes within a year.
- Nearest to marketPERT-IJS, SYSA1901 have reached phase 3, the last trial before a filing.
- Further outBCD-178, EG1206A are still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from four to ten. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so eight 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 | Poherdy | Shanghai Henlius Biotech, Inc. | Nov 2025 | 761450 | Interchangeable | Approved | S001, S016 |
| EMA | Poherdy | Organon N.V. | Apr 2026 | EMEA/H/C/006583 | Approved | S017 | |
| EMA | Application 006844 | Applicant not yet named by EMA | since Dec 2025 | EMEA/H/C/006844 | Under review | S019 | |
| EMA | Application 006893 | Applicant not yet named by EMA | since Jun 2026 | EMEA/H/C/006893 | Under review | S019 | |
| MHRA | Poherdy | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| CDSCO | Zydus Lifesciences (INN only) | Zydus Lifesciences Limited | Apr 2024 | MF/BIO/24/000041 | Approved | S011 | |
| CDSCO | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals Ltd | Jan 2025 | MF/BIO/25/000006 | Approved | S011 | |
| CDSCO | Enzene Biosciences (INN only) | Enzene Biosciences Ltd | Jun 2025 | MF/BIO/25/000085 | Approved | S011 |
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 pertuzumab 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 pertuzumab programmes. Regulatory strategy consulting
Presentations and concentration
A single presentation, 420 mg in 14 mL (30 mg/mL) concentrate for infusion. The subcutaneous combination with trastuzumab (Phesgo) exists only for the reference product.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Poherdy HLX11 | 420 mg/14 mL vial | see SmPC | 420 mg vial | · | · | · | · |
| Zydus pertuzumab | · | · | · | · | · | 420 mg/14 mL (30 mg/mL) vial | · |
| Intas pertuzumab | · | · | · | · | · | 420 mg/14 mL (30 mg/mL) vial | · |
| Enzene Biosciences pertuzumab | · | · | · | · | · | 420 mg/14 mL (30 mg/mL) vial | · |
| EU application 006844 | · | see SmPC | · | · | · | · | · |
| EU application 006893 | · | see SmPC | · | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Shanghai Henlius Biotech | Poherdy | ✓ | ✓ | ✓ | · | · | · | · |
| Zydus Lifesciences | Zydus pertuzumab | · | · | · | · | · | ✓ | · |
| Intas Pharmaceuticals | Intas pertuzumab | · | · | · | · | · | ✓ | · |
| Enzene Biosciences (Alkem) | Enzene Biosciences pertuzumab | · | · | · | · | · | ✓ | · |
| Applicant not yet named by EMA | EU application 006844 | · | review | · | · | · | · | · |
| Applicant not yet named by EMA | EU application 006893 | · | review | · | · | · | · | · |
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
Poherdy
Zydus pertuzumab
Intas pertuzumab
Enzene Biosciences pertuzumab
EU application 006844
EU application 006893
In development
ClinicalTrials.gov holds five comparative trials of five pertuzumab biosimilar candidates against the reference product, run by five sponsors. Four of the candidates (BCD-178, EG1206A, PERT-IJS, SYSA1901) 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 |
|---|---|---|---|---|---|---|---|---|---|
| BCD-178 | Biocad | Perjeta | Phase 1 | Comparative PK | Unknown, last active, not recruiting | Aug 2022 | Apr 2023 | no approval in the seven markets | NCT05738993 |
| PERT-IJS | Biocon Biologics | Perjeta | Phase 3 | Comparative efficacy | Terminated | Jan 2025 | Dec 2025 | no approval in the seven markets | NCT06038539 |
| SYSA1901 | CSPC | Perjeta | Phase 3 | Comparative efficacy | Unknown, last recruiting | Jan 2023 | Aug 2025 | no approval in the seven markets | NCT05720026 |
| EG1206A | EirGenix | Perjeta | Phase 1 | Comparative PK | Completed | May 2022 | Jan 2023 | no approval in the seven markets | NCT05471648 |
| HLX11 | Shanghai Henlius Biotech | Perjeta | Phase 3 | Comparative efficacy | Active, not recruiting | Apr 2022 | May 2024 | Poherdy | NCT05346224 |
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 pertuzumab biosimilar?
Zydus's product in India in 2024. In the United States and Europe, Henlius's Poherdy in 2025 and 2026.
Is there a biosimilar of the combined under-the-skin injection?
No. Roche's Phesgo, which combines pertuzumab and trastuzumab, is a separate product with no biosimilar anywhere.
Is there a pertuzumab biosimilar in the UAE?
Not yet. Perjeta and Phesgo are registered.
How is a pertuzumab biosimilar tested?
Laboratory comparison, a study in healthy volunteers, and a clinical comparison in women treated before breast surgery, together with trastuzumab and chemotherapy.
Are pertuzumab biosimilars interchangeable in the United States?
Yes. Poherdy was designated on the day of its approval.
Which Indian companies make pertuzumab?
Zydus, Intas and Enzene hold manufacturing permissions.
Work with EvySaif on pertuzumab
Pertuzumab 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 pertuzumab, 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)S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 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 pertuzumab biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
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