Stelara (ustekinumab) now has multiple FDA-licensed biosimilars, including Wezlana, the first designated interchangeable, so buyers can choose branded or biosimilar supply on the same cold chain.
Stelara (ustekinumab) remains the reference brand for plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. Since 2023 the FDA has licensed a growing field of ustekinumab biosimilars, among them Wezlana, Pyzchiva, Steqeyma, Selarsdi, Otulfi, Yesintek and Imuldosa. M Care sources both the originator and licensed biosimilar lines through Indian distribution channels as a merchant exporter, and moves the product on cold-chain validated lanes to hospital and tender buyers.
Ustekinumab exporter and bulk supplier from India.
For tender and bulk hospital orders, M Care quotes ustekinumab against a specified brand or biosimilar, batch quantity and destination market, then confirms sourcing through the relevant licensed Indian channel before dispatch. Because this is a temperature-sensitive biologic, every consignment moves on a validated 2-8C cold chain with continuous data-logger monitoring from origin to destination, and the CTD/eCTD dossier and batch release documentation are prepared alongside the shipment so MoH and NGO procurement desks can clear import without delay.
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.
Human IgG1 kappa monoclonal antibody, interleukin-12 and interleukin-23 antagonist (anti-p40 subunit), sourced and documented for export.
Ustekinumab is a human IgG1 kappa monoclonal antibody that binds the shared p40 subunit of interleukin-12 and interleukin-23, blocking their interaction with the IL-12Rbeta1 receptor on immune cells. This dual cytokine blockade interrupts the Th1 and Th17 inflammatory pathways implicated in plaque psoriasis and inflammatory bowel disease.
Stelara is licensed, per the current FDA label, for moderate to severe plaque psoriasis in adults and paediatric patients from age 6, active psoriatic arthritis in adults and paediatric patients from age 6, moderately to severely active Crohn's disease in adults and paediatric patients from age 2, and moderately to severely active ulcerative colitis in adults. Other licensed indications may apply per destination-country labelling.
The product is supplied as a solution for subcutaneous injection in prefilled syringe or single-use vial, and as a single-use vial for intravenous infusion used for induction dosing in Crohn's disease and ulcerative colitis. All presentations require storage at 2C to 8C, refrigerated, and must stay in the original carton to protect from light until use.
Active ingredient
ustekinumab. Human IgG1 kappa monoclonal antibody, interleukin-12 and interleukin-23 antagonist (anti-p40 subunit).
Forms and strengths
45 mg/0.5 mL prefilled syringe; 90 mg/mL prefilled syringe; 45 mg/0.5 mL single-use vial; 130 mg/26 mL single-use vial (IV infusion).
Indications
Licensed, per FDA label indications, for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and paediatric patients from age 6, moderately to severely active Crohn's disease in adults and paediatric patients from age 2, and moderately to severely active ulcerative colitis in adults.
Administration
subcutaneous, intravenous. Solution for injection in prefilled syringe or single-use vial (subcutaneous); solution for infusion in single-use vial (intravenous, for induction dosing).
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 include NHS trust and hospital pharmacy procurement teams managing biologic formularies, MoH tender desks in the GCC and Africa procuring for dermatology and gastroenterology programmes, licensed importers and wholesalers distributing specialist biologics, and NGO or health-system procurement officers evaluating biosimilar switch programmes for cost management.
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 ustekinumab.
Maintenance subcutaneous dosing on Stelara follows a weight-banded schedule: patients under 100 kg receive 45 mg at week 0 and week 4, then 45 mg every 12 weeks; patients over 100 kg receive 90 mg at week 0 and week 4, then 90 mg every 12 weeks. For Crohn's disease and ulcerative colitis, induction is a single weight-based intravenous infusion followed by subcutaneous maintenance dosing, so pharmacy needs to stock both the IV vial and the SC pen or syringe presentations to cover a patient through induction and maintenance. Paediatric dosing is weight- and age-banded separately per the label and should be checked against the specific indication and age group before dispensing.
Cold chain is the operational risk point for this product. Vials and prefilled syringes must stay at 2C to 8C throughout transit and storage, protected from light in the original carton, and must not be frozen or shaken. Confirm the destination pharmacy has continuous cold-chain capacity before committing to a delivery date, particularly for GCC and African tender lanes with longer last-mile transit.
Wezlana was the first ustekinumab biosimilar to carry an FDA interchangeability designation, meaning it can be substituted for Stelara at pharmacy level under US practice without prescriber sign-off. Several other listed biosimilars, including Selarsdi, Steqeyma, Otulfi, Yesintek and Imuldosa, have since received their own FDA interchangeability designations; Pyzchiva's interchangeability status has also progressed but should be checked directly, as designations continue to be updated. Buyers should confirm the current interchangeability status attached to each FDA licence before treating any biosimilar as automatically substitutable in their own market's regulatory framework, since substitution rules vary by destination country.
Watch for injection-site reactions with SC dosing and infusion-related reactions with the IV induction dose; standard practice is to observe patients during and after IV infusion per local protocol, consistent with the monitoring guidance in the prescribing information.
The documentation pack a regulator actually asks for.
Ustekinumab is a biologic, so every consignment M Care handles carries batch-specific certificates of analysis, cold-chain data-logger records for the full transit, and CTD/eCTD-format dossier support to help the receiving regulator clear import. M Care does not manufacture ustekinumab or hold WHO-GMP or WHO-PQ status itself; it sources Stelara and its licensed biosimilars through licensed Indian distribution and WHO-GMP partner sites as a merchant exporter, and every shipment is backed by CDSCO export documentation from the Indian side.
On the brand question: Stelara is the originator. Its principal US composition patent expired in September 2023, and following subsequent patent settlements a growing number of FDA-licensed biosimilars have launched in the US market since 2025; patent and market-exclusivity status in other countries varies and should be confirmed for the specific destination. The FDA-licensed biosimilars named above are separate, independently licensed products, not generic copies. Buyers should specify which product, brand or biosimilar, they want quoted, since substitution status and destination-market licensing differ by product and by country.
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 ustekinumab.
Adalimumab
Another allergy & immunology line ordered on the same formularies.
Etanercept
Another allergy & immunology line ordered on the same formularies.
Infliximab
Another allergy & immunology line ordered on the same formularies.
All allergy & immunology
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 ustekinumab.
- 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.
Ustekinumab supply, the specific questions.
Is there a generic version of Stelara?
There is no small-molecule generic, because ustekinumab is a biologic. What exists instead are FDA-licensed biosimilars, including Wezlana, Pyzchiva, Steqeyma, Selarsdi, Otulfi, Yesintek and Imuldosa. Wezlana was the first to carry an FDA interchangeability designation, and several of the others have since received their own interchangeability designations too; buyers should confirm current status and substitution rules for their destination market.
Can M Care supply Stelara to my market?
Yes. M Care sources Stelara through licensed Indian distribution channels as a merchant exporter and moves it on validated cold chain. Import is arranged on the basis applicable in your destination market, whether that is a named-patient route, MoH registration, or tender award, and we prepare the dossier support to match.
How is ustekinumab kept stable in transit?
Every consignment moves refrigerated at 2C to 8C with continuous data-logger monitoring from dispatch to delivery, in the original light-protective carton. We confirm the receiving pharmacy's cold-chain capacity before scheduling dispatch, which matters most on longer GCC and African tender lanes.
What is the difference between Wezlana and the other ustekinumab biosimilars?
All are FDA-licensed biosimilars to Stelara. Wezlana was the first to receive an FDA interchangeability designation, and several other ustekinumab biosimilars, including Selarsdi, Steqeyma, Otulfi, Yesintek and Imuldosa, have since received their own interchangeability designations. Check each product's current regulatory status for your specific destination market before assuming automatic substitutability, since designations and country-level substitution rules continue to evolve.
What indications is Stelara licensed for?
Per the FDA label: moderate to severe plaque psoriasis in adults and paediatric patients from age 6, active psoriatic arthritis in adults and paediatric patients from age 6, moderately to severely active Crohn's disease in adults and paediatric patients from age 2, and moderately to severely active ulcerative colitis in adults. Other licensed indications may apply per destination-country labelling.
Does M Care hold manufacturing or WHO-PQ status for ustekinumab?
No. M Care is a merchant exporter, not a manufacturer. We do not hold WHO-GMP or WHO-PQ status ourselves; we source ustekinumab and its biosimilars through licensed Indian distribution channels and WHO-GMP partner sites, and handle export documentation, cold chain and dossier support.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-26.
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.