Prolia and Xgeva are the same antibody, denosumab, sold as two different products: Prolia is 60 mg every six months for osteoporosis, Xgeva is 120 mg every four weeks for cancer-related bone events.
Prolia (denosumab 60 mg) and Xgeva (denosumab 120 mg) are not interchangeable products, even though both are denosumab from Amgen. M Care sources both, plus the FDA-licensed Prolia biosimilar Jubbonti, through licensed Indian distribution channels. We are a merchant exporter: we do not manufacture denosumab, we move genuine cold-chain stock to hospitals, importers and tender desks across our served markets.
Denosumab exporter and bulk supplier from India.
For MoH tender desks and hospital group buyers, the first question is always which product: Prolia for an osteoporosis formulary line, or Xgeva for an oncology bone-metastasis or giant cell tumour protocol. M Care quotes both separately, since they carry different NDC/pack codes, different pricing tiers and different clinical sign-off requirements at destination. Cold-chain validated lanes (2-8C throughout) apply to every consignment, with temperature logging supplied alongside the CTD/eCTD-aligned documentation pack. Where a buyer's protocol permits substitution to the licensed biosimilar Jubbonti for the Prolia indications, we can quote that alongside the originator line so the tender desk can compare.
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.
RANKL inhibitor, human monoclonal antibody (IgG2), sourced and documented for export.
Denosumab is a fully human monoclonal antibody (IgG2) that binds RANKL, the signal osteoclasts need to form, function and survive. Blocking RANKL reduces bone resorption. The same antibody is formulated at two different strengths for two different clinical uses.
Prolia (60 mg/mL, prefilled syringe, dosed every 6 months) is licensed for postmenopausal osteoporosis at high fracture risk, to increase bone mass in men with osteoporosis at high fracture risk, for glucocorticoid-induced osteoporosis in patients at high risk of fracture, and to increase bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer and in women on adjuvant aromatase inhibitor therapy for breast cancer. Xgeva (120 mg/1.7 mL vial, dosed every 4 weeks) is licensed for prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumours, for unresectable giant cell tumour of bone, and for hypercalcaemia of malignancy resistant to bisphosphonates.
Both are supplied as solution for subcutaneous injection and must be held refrigerated at 2-8C from origin to point of use. Once removed from the cold chain, product must be used within the manufacturer's stated room-temperature window, not re-refrigerated and reused indefinitely.
Active ingredient
denosumab. RANKL inhibitor, human monoclonal antibody (IgG2).
Forms and strengths
60 mg/mL (Prolia, prefilled syringe); 60 mg/mL (Jubbonti, prefilled syringe); 120 mg/1.7 mL, 70 mg/mL (Xgeva, single-dose vial).
Indications
Human monoclonal antibody against RANKL, licensed as Prolia (60 mg/6-monthly) for osteoporosis and related bone-loss indications, and as Xgeva (120 mg/4-weekly) for prevention of skeletal-related events in malignancy, giant cell tumour of bone, and hypercalcaemia of malignancy.
Administration
subcutaneous. Solution for injection, prefilled syringe (Prolia/Jubbonti) or single-dose vial (Xgeva).
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.
Hospital pharmacy departments running osteoporosis or oncology bone-support formularies, MoH tender desks in the GCC and African markets we serve, NGO and cancer-treatment procurement bodies sourcing Xgeva for skeletal-related-event protocols, and licensed importers and wholesalers stocking Prolia for outpatient osteoporosis clinics. Buyers should confirm at quote stage whether the requirement is the osteoporosis product or the oncology product, since the two are never interchangeable on a formulary line.
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 denosumab.
The dosing schedules are not close: Prolia is 60 mg subcutaneously once every 6 months, Xgeva is 120 mg subcutaneously every 4 weeks, with additional loading doses on days 8 and 15 of the first month for giant cell tumour of bone and hypercalcaemia of malignancy. A pharmacy that stocks both needs separate protocols and separate patient-education material; a dispensing error swapping the two products would under- or over-dose a patient significantly.
Both products require correction of pre-existing hypocalcaemia before the first dose, and calcium plus vitamin D supplementation is specified on the Prolia label (1000 mg calcium and at least 400 IU vitamin D daily). Renal-impairment patients, especially those with advanced kidney disease or on dialysis, carry a materially higher hypocalcaemia risk with either product and need closer monitoring of serum calcium.
Dental status should be checked before the first dose of either product: osteonecrosis of the jaw has been reported with denosumab, and invasive dental work is best completed first where possible. Atypical femoral fracture is a labelled risk for both products; patients on longer-term therapy who report new thigh, hip or groin pain need clinical review.
Cold chain is unforgiving. Store at 2-8C in the original carton, protected from light. Prolia and Jubbonti may be brought to room temperature (up to 25C) for 15-30 minutes immediately before injection; Xgeva, once removed from refrigeration, must be used within 30 days at or below 25C and not returned to the fridge. Every M Care consignment ships on a validated cold-chain lane with temperature logging, and we flag any excursion before dispatch confirmation.
The documentation pack a regulator actually asks for.
Denosumab is a biologic, so the documentation chain runs on batch-level cold-chain evidence as much as on dossier paperwork: temperature logs for the full transit, certificate of analysis per batch, and CTD/eCTD-format regulatory documentation to support destination-country registration or import licensing. M Care authors and assembles this pack for every denosumab consignment regardless of which of the two products is being shipped, and sources through licensed Indian distribution channels supplied by WHO-GMP manufacturing sites; M Care itself does not hold WHO-GMP or WHO-PQ status and does not manufacture denosumab.
On the brand-versus-biosimilar question: Jubbonti (denosumab-bbdz, Sandoz) is FDA-licensed as biosimilar to Prolia, covering the osteoporosis indications only, not the Xgeva oncology indications. It is not designated interchangeable, so destination-market substitution rules should be checked locally before a tender desk specifies it in place of Prolia. We quote Jubbonti alongside Prolia on request so buyers can compare on a like-for-like basis; we do not represent it as a biosimilar to Xgeva, since none of the products in our verified registry is licensed against that reference.
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 denosumab.
Deflazacort
Another musculoskeletal & pain line ordered on the same formularies.
Etoricoxib
Another musculoskeletal & pain line ordered on the same formularies.
Febuxostat
Another musculoskeletal & pain line ordered on the same formularies.
All musculoskeletal & pain
The full category listing for procurement desks.
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 denosumab.
- 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.
Denosumab supply, the specific questions.
Are Prolia and Xgeva the same drug?
Same active antibody, denosumab, but different products. Prolia is 60 mg every 6 months for osteoporosis. Xgeva is 120 mg every 4 weeks for cancer-related bone complications. They are not substitutable for each other and carry separate licensing, dosing and pack codes.
Is there a generic or biosimilar version of denosumab?
There is no small-molecule generic, since denosumab is a biologic. An FDA-licensed biosimilar, Jubbonti (denosumab-bbdz, Sandoz), is approved against Prolia for the osteoporosis indications. It is not licensed as biosimilar to Xgeva. Jubbonti is not designated interchangeable, so check destination-country substitution rules before specifying it in place of Prolia on a tender.
How is denosumab shipped and stored?
As a refrigerated biologic, 2-8C from manufacture to point of use. M Care ships denosumab on validated cold-chain lanes with temperature logging supplied per consignment. Once removed from refrigeration, both Prolia/Jubbonti and Xgeva have manufacturer-defined room-temperature windows that must not be exceeded or repeated.
Can M Care supply Prolia or Xgeva to our market?
Yes. M Care is a merchant exporter and sources both products through licensed Indian distribution channels, in line with the destination country's own import and registration requirements. We do not manufacture denosumab; we handle sourcing, documentation and cold-chain logistics for the consignment.
What documentation comes with a denosumab order?
A CTD/eCTD-aligned documentation pack, batch certificate of analysis, and full cold-chain temperature logs for the shipment. We flag any temperature excursion before confirming dispatch.
Which indication should I specify when requesting a quote?
Tell us the intended use, osteoporosis (Prolia line) or oncology bone-event prevention (Xgeva line), so we quote the correct product, strength and pack. The two are priced, packed and regulated separately.
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.