Trastuzumab biosimilar — Indian WHO-GMP supply for HER2-positive breast and gastric cancer.
Anti-HER2 humanised IgG1 monoclonal antibody — the targeted therapy that turned HER2-positive breast cancer into an adjuvant-curable disease. 100mg, 150mg and 440mg lyophilised vials from Indian WHO-GMP biosimilar facilities, with EMA and MHRA biosimilar comparability dossier on file and 2-8°C cold-chain validated end-to-end.
Multiple WHO-GMP biosimilar partner lines · 100mg / 150mg / 440mg lyophilised vials · CTD biosimilar comparability dossier on file · 2-8°C cold-chain validated.
Active ingredient
Trastuzumab, a recombinant humanised anti-HER2 (ErbB2) IgG1 monoclonal antibody. Mechanism: binds the extracellular domain IV of HER2, inhibits HER2 homo- and hetero-dimerisation, blocks downstream PI3K/Akt and MAPK signalling, induces ADCC (antibody-dependent cellular cytotoxicity) via FcγRIII engagement on NK cells. Biosimilar comparability covers identical primary structure, comparable post-translational modifications (glycosylation profile, charge variants), comparable potency in HER2-binding and ADCC functional assays.
Strengths stocked
100mg single-use vial (paediatric and dose-titration), 150mg single-use vial (standard adult weight-based dosing), and 440mg multi-dose vial (high-volume tender supply). All lyophilised, reconstituted with bacteriostatic water for injection (BWFI, contains 1.1% benzyl alcohol — 440mg vial only) or sterile water for injection (single-use 100mg/150mg). Final solution further diluted in 0.9% NaCl (NOT 5% glucose — incompatibility) for IV infusion.
Indications
HER2-positive early breast cancer (adjuvant + neoadjuvant — AC-TH, TCH, FEC-TH); HER2-positive metastatic breast cancer (first-line and beyond, with taxane); HER2-positive metastatic gastric / GEJ adenocarcinoma (ToGA regimen with cisplatin + capecitabine). Loading dose 8 mg/kg, maintenance 6 mg/kg every 3 weeks (or weekly 4 + 2 mg/kg in some protocols). 1-year adjuvant duration is the standard.
Storage
2-8°C, do not freeze, protect from light. Lyophilised vial 36 months shelf life. Reconstituted with BWFI: 28 days at 2-8°C in the multi-dose vial; reconstituted with sterile water (single-use): 24 hours at 2-8°C. Further-diluted infusion in 0.9% NaCl: 24 hours at 2-8°C, 4 hours at room temperature. Do not use 5% glucose — incompatibility, aggregate formation.
Shelf life
36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
Single vial per carton. Type-I clear glass vial, halobutyl rubber stopper, aluminium seal with flip-off cap. Outer carton and leaflet in destination-regulator language. LVEF cardiotoxicity-monitoring schedule and infusion-reaction pre-medication guidance prominently set on the SmPC. Biosimilar batch-traceability label per EMA and MHRA biosimilar pharmacovigilance requirement (lot number printed on outer carton AND patient leaflet for traceability across switching).
NHS biosimilar formulary, GCC NUPCO biosimilar tenders, African public-sector oncology — across thirty markets.
India is our origin. We do not sell into the Indian market. Trastuzumab biosimilar is exported only.
United Kingdom
NHS England biosimilar switch policy mandates biosimilar trastuzumab as first-line for new HER2+ breast and gastric cancer patients since 2018. M Care biosimilar lines are MHRA-licensed-supplier-aligned. Where the primary biosimilar contract holder cannot fill demand, the MHRA Specials / named-patient import route covers the gap — see MHRA Specials. Biosimilar batch-traceability label is critical for PV and is on every consignment.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH biosimilar tender awards (NUPCO biosimilar oncology tenders are a major channel — Saudi MoH explicit biosimilar-substitution policy since 2019; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH Central Drug Store; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain) and hospital pharmacy purchase orders. SFDA, MoHAP and GCC central registration support the biosimilar comparability dossier filing.
Nigeria, Kenya, Ghana, South Africa, Ethiopia
Public-sector oncology biosimilar tenders (NAFDAC-registered for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA-registered for South Africa — Netcare and Mediclinic oncology centres are key buyers, EFDA + EPSS for Ethiopia). Affordability is the driving factor — biosimilar trastuzumab pricing is 50-70% below originator. Global Fund and Africa CDC biosimilar-pathway tenders supported.
Germany, France, Brazil, Mexico
Supply via licensed importers under §72 AMG (Germany, with QP certification on EU arrival per biosimilar regulatory pathway), ANSM equivalent (France), ANVISA biosimilar equivalent (Brazil), COFEPRIS (Mexico). EMA biosimilar comparability dossier prepared per EMA/CHMP/BMWP guidelines with full Module 3 + extrapolation justification. Named-patient (Einzelimport) route available for the German channel.
LVEF monitoring, infusion-reaction pre-medication, and 0.9% saline only — trastuzumab is forgiving until you skip the basics.
Adult IV trastuzumab is dosed weight-based: loading 8 mg/kg over 90 minutes, maintenance 6 mg/kg over 30 minutes every 3 weeks; or weekly schedule (4 mg/kg load, 2 mg/kg/week). Adjuvant duration is 1 year (17 cycles of 3-weekly), shorter under PERSEPHONE 6-month evidence in some protocols. Subcutaneous formulation (separate product listing) is fixed-dose 600mg every 3 weeks, no weight-based calculation. LVEF monitoring is mandatory: baseline echocardiogram or MUGA, then every 3 months during therapy and at completion. LVEF drop ≥10% from baseline with absolute value <50% triggers temporary withhold + re-evaluation in 3 weeks. Cardiotoxicity is largely reversible if recognised early. Concurrent anthracycline (doxorubicin) is the major cardiac risk multiplier — sequential AC-TH (anthracycline first, taxane + trastuzumab second) is standard, NOT concurrent. Infusion reactions (chills, fever, nausea) are common with the first dose; pre-medicate with paracetamol 1g + diphenhydramine 25-50mg + IV fluids. CIRR (complement-mediated infusion reaction) is rare but managed with infusion slowdown and observation. Diluent: 0.9% sodium chloride only; 5% glucose causes aggregate formation and is contraindicated. Do not mix with other drugs in the same line. Pulmonary toxicity (interstitial pneumonitis) is rare but documented. Pregnancy is contraindicated (oligohydramnios, neonatal renal impairment); contraception during therapy and for 7 months after.
The documentation pack a regulator actually asks for — biosimilar comparability is the differentiator.
Trastuzumab biosimilar is a complex biological product — the regulatory pack is more demanding than a small-molecule generic. Our role is manufacturer-facing — we sit between the Indian WHO-GMP biosimilar facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3 + biosimilar comparability
Full chemistry, manufacturing and controls section per ICH Q5A-Q5E and EMA biosimilar guidelines (CHMP/437/04, CHMP/BMWP guidelines for monoclonal antibodies). Biosimilar comparability exercise covers physico-chemical characterisation (size, charge, glycosylation, post-translational modifications), in-vitro functional assays (HER2-binding affinity, ADCC, CDC, downstream signalling inhibition), and clinical pharmacology bridging study (PK + PD biomarkers in HER2+ breast cancer patients per EMA scientific advice).
CoA and MoA, per batch
ELISA quantitation (mg/ml); identity by peptide mapping LC-MS/MS, isoelectric focusing, capillary electrophoresis; size variants by SEC-HPLC, SDS-PAGE; charge variants by IEC-HPLC; glycan profile by HILIC-FLR; potency by HER2-binding ELISA + ADCC reporter bioassay; aggregates and fragments by AUC + DLS; bioburden, sterility, bacterial endotoxin, host-cell protein residual (CHO HCP), residual host-cell DNA — signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Biosimilar facility licence and EMA / MHRA biosimilar inspection certificates (where applicable) included. Notarised copies in the shipping pack.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards. Biosimilar batch-traceability label per EMA / MHRA biosimilar pharmacovigilance requirement: lot number on outer carton AND patient leaflet to enable traceability across multiple-biosimilar switching. LVEF monitoring schedule and infusion-reaction pre-medication guidance prominently set.
Temperature control
Pre-shipment validation on each shipper configuration. 2-8°C cold-chain mandatory throughout transit, no freezing. Active-cooled containers (Envirotainer, Cool Containers) for trans-continental shipments; passive PCM coolers with 96h temperature stability for shorter lanes. Cold-tail and hot-tail excursion protocols both documented; on-arrival cold-chain integrity check before pharmacy hand-over.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C plus the biosimilar-specific traceability requirement (every adverse event must reference the specific biosimilar brand by INN + manufacturer + lot number). Cardiotoxicity (LVEF decline, symptomatic heart failure), infusion reactions, pulmonary toxicity, and neonatal renal events from inadvertent in-utero exposure remain the PSUR priority signals.
AC-TH, TCH, FEC-TH and the biosimilar oncology cluster.
Trastuzumab regimens combine with anthracyclines (sequentially), taxanes (concurrently), platinum agents (gastric ToGA), and CDK4/6 inhibitors (HER2+ MBC research). We carry the supporting cluster.
Doxorubicin
Anthracycline, the 'A' in AC-TH (sequential, NOT concurrent). 10mg / 50mg / 200mg + 20mg PEGylated.
Cyclophosphamide
Alkylating agent, the 'C' in AC-TH and TCH. 200mg / 500mg / 1g / 2g vials.
Paclitaxel
Taxane, the 'T' in TH (paclitaxel + trastuzumab). 30mg / 100mg / 260mg concentrate.
Docetaxel
Taxane, the 'T' in TCH (docetaxel + carboplatin + trastuzumab). 20mg / 80mg / 120mg.
Carboplatin
Platinum, the 'C' in TCH. 50mg / 150mg / 450mg vials.
All oncology →
120+ oncology SKUs: cytotoxics, targeted therapy, biosimilars, supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (100mg / 150mg single-use, or 440mg multi-dose), vial count, destination, NHS biosimilar formulary / GCC NUPCO biosimilar tender / African public-sector / NGO supply, target delivery. Flag if biosimilar comparability dossier or EMA biosimilar batch-traceability material is needed for the receiving formulary committee.
- We route to the right line. Multiple WHO-GMP biosimilar trastuzumab lines on the M Care roster, including EMA-licensed biosimilar manufacturer facilities and MHRA-recognised biosimilar lines. Registered-market preference goes to facilities already holding the relevant destination biosimilar registration.
- Commercial and regulatory offer. FOB / CIF price (typically 50-70% below originator), lead time, biosimilar comparability dossier status per destination, batch-traceability label compliance, cold-chain lane validation report, and the documentation pack. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. 2-8°C cold-chain dispatch, no freezing, active or passive cooled container per lane, in-transit temperature logging with cold-tail and hot-tail excursion protocols, on-arrival cold-chain integrity check. Photo evidence of seal integrity and thermal-log validation on request.
- After delivery. Batch records, CoA, MoA and cold-chain logs archived for the full shelf life. Pharmacovigilance contact opened on registration with biosimilar-specific traceability per EMA / MHRA requirement; cardiotoxicity, infusion reactions and neonatal renal events from inadvertent in-utero exposure remain the PSUR priority signals.
Trastuzumab biosimilar supply — the specific questions.
What strengths and formulations of trastuzumab do you supply?
Lyophilised IV: 100mg single-use vial (paediatric, dose-titration), 150mg single-use vial (standard adult weight-based dosing), 440mg multi-dose vial (high-volume tender supply, reconstituted with BWFI for 28-day stability). All single-use vials reconstituted with sterile water for injection; multi-dose with bacteriostatic water for injection. Final dilution in 0.9% NaCl ONLY (5% glucose is incompatible — aggregate formation). Subcutaneous trastuzumab (separate ready-to-use formulation, fixed-dose 600mg/5ml every 3 weeks) is a separate listing in our biosimilar catalogue. Pack is one vial per carton in hospital pack.
Is your trastuzumab biosimilar approved by EMA / MHRA / FDA?
We supply biosimilar trastuzumab from manufacturers that hold EMA biosimilar approvals (CHMP positive opinions issued from 2017 onwards) and MHRA biosimilar approvals. Specific manufacturer EMA/MHRA approval status is shared against NDA per consignment — different M Care partner facilities hold different destination-market approvals, and we route the order to the line with the relevant approval for your destination. FDA-approved biosimilars are a separate approval pathway (US BLA 351(k)) which is not relevant to most of our markets but available for specific destinations on request. The manufacturer-side biosimilar comparability dossier per EMA CHMP/437/04 and CHMP/BMWP/403543/2010 (mAbs) is included in the destination registration filing.
Can you supply trastuzumab biosimilar against NUPCO biosimilar oncology tenders?
Yes — NUPCO (National Unified Procurement Company, Saudi Arabia) biosimilar oncology tenders are a major M Care channel. Saudi MoH biosimilar substitution policy since 2019 means new HER2+ breast and gastric cancer patients receive biosimilar trastuzumab as first-line. Our biosimilar comparability dossier per CHMP guidelines plus SFDA-recognised biosimilar registration is on file; we route NUPCO-awarded volume through the partner facility holding the relevant SFDA biosimilar approval. NUPCO tender-award documentation, batch-specific compliance pack, and 2-8°C cold-chain validated lane to Riyadh / Jeddah are standard. King Faisal Specialist Hospital and SEHA oncology centres are key end-customer formularies.
Which markets can you ship trastuzumab biosimilar into?
The UK (NHS biosimilar formulary supply, MHRA-aligned biosimilar lines), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — biosimilar tender channel is the primary route — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia) for public-sector tenders with WHO PQ pathway support where applicable, Egypt, Jordan on the Levant side, Germany under §72 AMG with QP biosimilar certification, France under ANSM biosimilar pathway, Brazil (ANVISA biosimilar) and Mexico (COFEPRIS). We do not supply into India. Full market coverage is at markets.
What documentation is included with a trastuzumab biosimilar consignment?
Every consignment ships with a batch-specific Certificate of Analysis (ELISA quantitation, peptide mapping LC-MS/MS, IEF, CE-SDS, SEC-HPLC, IEC-HPLC, glycan profile by HILIC-FLR, HER2-binding ELISA potency, ADCC reporter bioassay, aggregates by AUC + DLS, host-cell protein, residual host-cell DNA, sterility, bacterial endotoxin), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, biosimilar manufacturing licence, EMA / MHRA biosimilar inspection certificate (where applicable), Certificate of Origin (chamber-attested), destination-language pack insert with biosimilar batch-traceability label and LVEF monitoring + infusion-reaction guidance, and cold-chain temperature logs from pre-dispatch through on-arrival. Biosimilar-specific PV contact nominated in the destination market on registration.
Do you provide CTD biosimilar comparability dossiers for trastuzumab registration?
Yes. Full CTD Module 3 plus biosimilar comparability annex per EMA CHMP/437/04 and CHMP/BMWP/403543/2010 (monoclonal antibodies guideline) is available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, BfArM, ANSM, ANVISA, COFEPRIS and comparable bodies. The comparability exercise covers physico-chemical characterisation, in-vitro functional assays (HER2-binding, ADCC, CDC, downstream signalling), clinical pharmacology bridging study, and indication-extrapolation justification. Lead time on a biosimilar dossier against a new registration is typically 8-12 weeks from NDA signature given the complexity. See dossier preparation.
What are typical lead times for trastuzumab biosimilar orders, and what's the cold-chain requirement?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (NUPCO, NHS biosimilar framework, KEMSA, SAHPRA), the lead time is set in the tender award document. Biosimilar mAbs have longer made-to-order lead times (12-16 weeks for a full batch including QC release) given the upstream cell-culture and downstream purification timeline. 2-8°C cold-chain is mandatory throughout transit, no freezing. Active-cooled containers (Envirotainer, Cool Containers) for trans-continental shipments; passive PCM coolers with 96h temperature stability for shorter lanes. Cold-chain integrity check on arrival is the gating quality step before pharmacy hand-over.
Send the specifics. You'll have a price inside one working day.
Strength, vial volume, single-use or multi-dose, destination, NHS biosimilar formulary / GCC NUPCO tender / African public-sector / Global Fund, target delivery, biosimilar comparability dossier requirement. That's the enquiry. Everything else is on us.