Perjeta (IV pertuzumab) now has a fixed-dose subcutaneous sibling, Phesgo, and a licensed biosimilar, Poherdy, so buyers choosing HER2 therapy have three sourcing routes to compare, not one.
Perjeta (pertuzumab) remains the reference HER2-targeted monoclonal antibody for HER2-positive breast cancer, given by IV infusion with trastuzumab and chemotherapy. Phesgo delivers the same two antibodies as a fixed-dose subcutaneous injection, cutting chair time for busy oncology day units. M Care sources all three, Perjeta, Phesgo and the Poherdy biosimilar, through licensed Indian export channels as a merchant exporter, never a manufacturer, and moves them on validated cold chain to tender desks and hospital pharmacies.
Pertuzumab exporter and bulk supplier from India.
For MoH tenders, NGO procurement rounds and hospital group contracts, M Care quotes Perjeta, Phesgo or Poherdy against the buyer's own specification, matching brand or biosimilar to what the tender document or formulary actually calls for. Every consignment moves on a cold-chain validated lane with temperature logging from origin to destination, backed by CTD/eCTD-ready documentation for import registration. Volumes, lead times and split-shipment schedules are agreed per contract; we do not publish prices.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
HER2/neu receptor antagonist, humanised monoclonal antibody (HER2 dimerisation inhibitor), sourced and documented for export.
Pertuzumab is a recombinant humanised monoclonal antibody (HER2/neu receptor antagonist) that binds domain II of the HER2 receptor, blocking ligand-independent HER2/HER3 dimerisation. It is used alongside trastuzumab, which binds a different HER2 epitope, giving complementary blockade rather than duplicate action.
Perjeta is licensed, in combination with trastuzumab and chemotherapy, for the neoadjuvant and adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence, and, with trastuzumab and docetaxel, for HER2-positive metastatic breast cancer in patients who have not had prior anti-HER2 therapy or chemotherapy for metastatic disease. Phesgo carries the same combination indications in a fixed-dose subcutaneous form. Other licensed indications may apply per destination-country labelling.
Perjeta and Poherdy are supplied as a 420 mg/14 mL (30 mg/mL) concentrate for solution for infusion in a single-dose vial. Phesgo is supplied as fixed-dose pertuzumab/trastuzumab/hyaluronidase vials for subcutaneous injection. All three are biologics requiring continuous 2C to 8C cold chain; none may be frozen or shaken.
Active ingredient
pertuzumab. HER2/neu receptor antagonist, humanised monoclonal antibody (HER2 dimerisation inhibitor).
Forms and strengths
420 mg/14 mL (30 mg/mL), IV concentrate, Perjeta; 420 mg/14 mL (30 mg/mL), IV concentrate, Poherdy biosimilar; 1200/600/30,000 mg pertuzumab / mg trastuzumab / units hyaluronidase, Phesgo loading dose, SC; 600/600/20,000 mg pertuzumab / mg trastuzumab / units hyaluronidase, Phesgo maintenance dose, SC.
Indications
Licensed, in combination with trastuzumab and chemotherapy, for neoadjuvant and adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence and, with trastuzumab and docetaxel, for HER2-positive metastatic breast cancer; other licensed indications per destination-country labelling.
Administration
intravenous infusion, subcutaneous injection. Concentrate for solution for IV infusion (Perjeta, Poherdy); fixed-dose pertuzumab/trastuzumab/hyaluronidase solution for subcutaneous injection (Phesgo).
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for this molecule are typically hospital oncology pharmacies and private cancer centres running HER2-positive breast cancer protocols, MoH tender desks in the GCC and Africa procuring HER2 biologics for national cancer programmes, NGO and Global Fund-aligned procurement offices sourcing cost-efficient biosimilar options, and licensed importers and wholesalers building an oncology portfolio for hospital-group distribution. Day-unit administrators evaluating a switch to subcutaneous therapy are a growing segment asking specifically about Phesgo.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on pertuzumab.
Dosing is not interchangeable by simple substitution across formats. IV Perjeta is 840 mg loading over 60 minutes, then 420 mg every three weeks over 30 to 60 minutes, always given with trastuzumab and infused before trastuzumab and any chemotherapy on the same visit. Phesgo is fixed-dose regardless of body weight: 1,200 mg pertuzumab / 600 mg trastuzumab / 30,000 units hyaluronidase subcutaneously over about 8 minutes as the loading dose, then 600 mg / 600 mg / 20,000 units over about 5 minutes every three weeks. Phesgo is injected into the thigh only and must never be given intravenously.
Switching a patient from IV Perjeta and Herceptin to Phesgo, or the reverse, should happen at a scheduled cycle boundary under the prescriber's own institutional protocol; the two are not dosed the same way and pharmacy systems should flag the change to avoid a nurse defaulting to IV rates for an SC product.
All three products need continuous 2C to 8C refrigeration from receipt through storage; vials stay in the outer carton to protect from light, and none may be frozen or shaken. Build any tender delivery schedule around validated cold-chain transit time, not just transit distance.
Poherdy is a licensed pertuzumab biosimilar to Perjeta from Henlius, commercialised outside China by Organon. Its FDA-approved label (interchangeable biosimilar status, approved November 2025) and its EU marketing authorisation via the European Commission (April 2026) both cover the same full indication set as Perjeta: neoadjuvant and adjuvant HER2-positive early breast cancer with trastuzumab and chemotherapy, and HER2-positive metastatic breast cancer with trastuzumab and docetaxel. Interchangeable status allowing pharmacy-level substitution without a new prescription applies in the US specifically; substitution rules for biosimilars vary by country outside the US and EU, so confirm the current label and local substitution policy before quoting Poherdy against a tender line written for Perjeta.
The documentation pack a regulator actually asks for.
Perjeta, Phesgo and Poherdy are biologics, not oral solids, so the documentation chain runs on cold-chain evidence as much as on the dossier itself: temperature logs for the full transit, vial-level batch and expiry traceability, and CTD/eCTD-format registration documents for the importing country's regulator. M Care sources through licensed Indian export channels and WHO-GMP partner sites and does not itself hold WHO-GMP, WHO-PQ, US FDA registration or an EU manufacturing licence; we operate as the merchant exporter arranging documented, validated supply, not as the manufacturer of record.
Poherdy carries its own marketing authorisation, from the FDA in the US (as an interchangeable biosimilar) and from the European Commission in the EU (as a biosimilar), both referencing Perjeta and covering the same indication set. Buyers building a tender specification should state whether Perjeta, Phesgo or Poherdy is required, or whether the specification is open to 'pertuzumab, brand or biosimilar per approved indication', so M Care can quote the correct match.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside pertuzumab.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for pertuzumab.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Pertuzumab supply, the specific questions.
Does a generic or biosimilar version of pertuzumab exist?
There is no small-molecule generic, pertuzumab is a biologic, but a licensed biosimilar exists: Poherdy (Henlius/Organon), approved by the FDA as an interchangeable biosimilar and by the European Commission as a biosimilar to Perjeta, both covering the same neoadjuvant, adjuvant and metastatic indications as Perjeta. Substitution rules outside the US and EU vary by regulator, so check the current label for the destination country before substituting it on a tender line.
What is the difference between Perjeta and Phesgo?
Both contain pertuzumab and trastuzumab. Perjeta is pertuzumab alone, given by IV infusion together with a separate trastuzumab infusion. Phesgo combines pertuzumab, trastuzumab and hyaluronidase in one fixed-dose subcutaneous injection, cutting a roughly 90-minute IV chair-time visit down to a single 5 to 8 minute injection after the first dose.
Can M Care supply Perjeta, Phesgo or Poherdy to our market?
Yes. M Care sources all three through licensed Indian export channels as a merchant exporter. Supply into any of our export markets is arranged against the buyer's own import licence and registration status; we handle CTD/eCTD-ready dossier documentation and cold-chain validated dispatch, and we advise on which product matches the buyer's specific import approval.
How is pertuzumab shipped and stored to protect the cold chain?
All three products need unbroken 2C to 8C refrigeration from dispatch to the pharmacy fridge, with vials kept in their outer carton to protect from light and never frozen or shaken. M Care dispatches on cold-chain validated lanes with temperature logging for the full transit, and we align delivery windows with the buyer's own cold-chain receiving capacity.
Is Phesgo dosed the same way as IV Perjeta?
No. Phesgo is a fixed dose given regardless of patient weight, injected into the thigh only, while Perjeta is dosed by fixed mg amount but given as an IV infusion timed before trastuzumab and chemotherapy. The two are not interchangeable at the point of administration without following the prescriber's own switch protocol.
What documentation does M Care provide for tender or import registration?
CTD/eCTD-format dossier support, batch-level cold-chain temperature records, CDSCO export licensure evidence and WHO-GMP partner-site sourcing documentation. We do not claim WHO-GMP or WHO-PQ status ourselves, as we are the exporter, not the manufacturer.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.