Pertuzumab biosimilars
Anti-HER2 antibody used with trastuzumab in HER2-positive breast cancer, with the first biosimilar approved in the US in November 2025 and three Indian manufacturers permitted since 2024.
About pertuzumab
Humanised IgG1 kappa monoclonal antibody of about 148 kDa, produced in Chinese hamster ovary cells, directed against extracellular domain II of HER2, a different site from the domain IV epitope bound by trastuzumab.
Blocks HER2 from forming ligand-dependent dimers with other HER family receptors, particularly HER3, which trastuzumab does not prevent; the two antibodies together give a more complete blockade of HER2 signalling. It also mediates antibody-dependent cellular cytotoxicity.
Intravenous infusion; half-life about 18 days, linear pharmacokinetics at clinical doses, steady state after the first maintenance dose. A subcutaneous fixed combination with trastuzumab and hyaluronidase exists for the reference product.
840 mg loading dose then 420 mg every three weeks with trastuzumab and chemotherapy, as 420 mg/14 mL (30 mg/mL) concentrate for infusion in single-dose vials.
- HER2-positive metastatic breast cancer with trastuzumab and docetaxel
- Neoadjuvant treatment of HER2-positive early breast cancer at high risk of recurrence
- Adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence
Anti-pertuzumab antibodies are rare and not clinically relevant. Comparative programmes use analytical similarity with attention to HER2 domain II binding and ADCC, a pharmacokinetic study, and a comparative efficacy study in the neoadjuvant setting with pathological complete response as the endpoint, in combination with trastuzumab and chemotherapy.
Perjeta was licensed by FDA on 8 June 2012 (BLA 125409) and authorised in the EU on 4 March 2013 (EMEA/H/C/002547). The first Indian biosimilar was permitted to Zydus in April 2024, and Henlius's Poherdy became the first US biosimilar in November 2025, interchangeable on licensure, followed by EU authorisation through Organon in April 2026. Roche's subcutaneous fixed combination with trastuzumab, Phesgo, has no biosimilar.
Sources: Purple Book (S016), EMA medicines data (S017), CDSCO lists (S011, S012, S013).
Pertuzumab is the natural second step for any developer with a trastuzumab biosimilar, since the two are given together and the neoadjuvant study design is the same. India moved first: Zydus in 2024, Intas and Enzene in 2025, all at the 420 mg/14 mL presentation, while the West has a single product from Henlius. Roche's defence is Phesgo, the subcutaneous combination, which has no biosimilar in any market.
Sources: Perjeta summary of product characteristics (EMA) and US prescribing information (FDA).
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 | |
| 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 |
CDSCO lists permissions by firm and INN, not brand. The UAE directory does not publish registration numbers.
Regulatory pathway by market
Requirements for a pertuzumab biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | 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 | 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 | 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 | 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 | 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 | 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).
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 | CDSCO | EDE |
|---|---|---|---|---|
| Poherdy HLX11 | 420 mg/14 mL vial | see SmPC | · | · |
| 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 | · |
Sources: Purple Book (S016), CDSCO permission lists (S011 to S014), EDE directory (S018). EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | CDSCO | EDE |
|---|---|---|---|---|---|
| Shanghai Henlius Biotech | Poherdy | ✓ | ✓ | · | · |
| Zydus Lifesciences | Zydus pertuzumab | · | · | ✓ | · |
| Intas Pharmaceuticals | Intas pertuzumab | · | · | ✓ | · |
| Enzene Biosciences (Alkem) | Enzene Biosciences pertuzumab | · | · | ✓ | · |
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
Questions
How many pertuzumab biosimilars has FDA approved?
One: Poherdy from Shanghai Henlius, approved on 13 November 2025 and designated interchangeable on the same day.
Which pertuzumab biosimilars are authorised in the European Union?
One: Poherdy, authorised on 23 April 2026 with Organon as the holder.
Is there a pertuzumab biosimilar approved in India?
Yes, three. CDSCO permitted Zydus Lifesciences in April 2024 (with early breast cancer added in August 2024), Intas Pharmaceuticals in January 2025 (neoadjuvant indication added February 2026) and Enzene Biosciences in June 2025.
Which pertuzumab biosimilars are registered in the UAE?
None yet in the Emirates Drug Establishment directory; Perjeta and Phesgo are registered.
Is there a biosimilar of Phesgo?
No. The subcutaneous fixed combination of pertuzumab, trastuzumab and hyaluronidase is a separate product with its own patents and no biosimilar in any market.
Which comparative efficacy study do regulators accept for pertuzumab?
A neoadjuvant study in HER2-positive early breast cancer, in combination with trastuzumab and chemotherapy, with total pathological complete response as the primary endpoint, supported by pharmacokinetic equivalence and analytical comparability of domain II binding and ADCC.
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)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)
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