Humira (adalimumab) now shares its US market with FDA-licensed biosimilars including Amjevita and Cyltezo, so buyers choose between the originator brand and a biosimilar on the same molecule.
Humira (adalimumab) remains the reference brand for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and non-infectious uveitis. FDA-licensed biosimilars, including Amjevita and Cyltezo, now compete on the same indications. M Care sources both the originator brand and licensed biosimilar lines through India-based licensed distribution channels, as a merchant exporter, not a manufacturer, and moves them on cold-chain validated lanes to hospital, tender and wholesale buyers.
Adalimumab exporter and bulk supplier from India.
For tender and bulk hospital demand, the Mumbai desk quotes adalimumab against a defined specification: brand name, strength (pen or prefilled syringe), pack size and destination-market regulatory pathway. Because both the originator and several biosimilars are commercially available, we build tender responses around whichever product line matches the buyer's formulary listing or interchangeability requirement, sourced through licensed Indian channels and dispatched on temperature-monitored lanes with shipment-level cold-chain documentation.
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.
Tumour necrosis factor-alpha (TNF-alpha) inhibitor, recombinant human IgG1 monoclonal antibody, sourced and documented for export.
Adalimumab is a recombinant human IgG1 monoclonal antibody that binds tumour necrosis factor-alpha (TNF-alpha) and blocks its interaction with cell-surface TNF receptors, reducing the inflammatory cascade in TNF-driven autoimmune disease.
Humira is FDA-licensed for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and non-infectious uveitis; destination-country labelling should be checked for the exact indication set approved by the local regulator. Amjevita and Cyltezo carry closely matched label indications as licensed biosimilars, with some line-by-line differences by strength and route.
All three are supplied as solution for injection in single-dose prefilled syringes or prefilled autoinjector pens, at strengths spanning 10 mg to 80 mg. They are biologics and require continuous 2-8°C cold-chain storage from manufacture through to patient administration, with a defined room-temperature excursion allowance described on the product label.
Active ingredient
adalimumab. Tumour necrosis factor-alpha (TNF-alpha) inhibitor, recombinant human IgG1 monoclonal antibody.
Forms and strengths
10 mg/0.1 mL; 20 mg/0.2 mL; 40 mg/0.4 mL; 40 mg/0.8 mL; 80 mg/0.8 mL.
Indications
Licensed for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and non-infectious uveitis per FDA label; other licensed indications apply per destination-country labelling.
Administration
subcutaneous. Solution for injection in prefilled syringe or prefilled autoinjector pen.
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 adalimumab through M Care include NHS trust and hospital pharmacies procuring against a formulary-listed brand or biosimilar, MoH tender desks in the GCC and Africa specifying a molecule rather than a brand, licensed wholesalers and importers who hold the destination market's biologic import authorisation, and NGO procurement bodies sourcing TNF-inhibitor therapy for rheumatology or IBD programmes where cost per treated patient drives the brand-versus-biosimilar decision.
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 adalimumab.
Dosing differs by indication. For rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, the standard adult maintenance dose is 40 mg subcutaneously every other week. Crohn's disease uses an induction regimen (160 mg on day 1, 80 mg at week 2) before the same 40 mg every-other-week maintenance dose; plaque psoriasis starts at 80 mg followed by 40 mg every other week from one week after the loading dose. Confirm the specific regimen against the destination-market label before dispensing, since indication-specific dosing is a common source of underdosing errors with this molecule.
All adalimumab products in this class are cold-chain biologics: store at 2-8°C, protect from light, and never freeze. The Humira label permits a single room-temperature excursion of up to 25°C for a defined period before the dose must be used or discarded; biosimilar labels carry their own excursion terms that are not automatically identical, so check the specific product insert rather than assuming Humira's allowance applies to Amjevita or Cyltezo.
Injection-site reactions (erythema, itching, swelling) are the most commonly reported adverse event across the class and are usually managed with site rotation and, where clinically appropriate, pre-injection warming of the syringe or pen to room temperature. Patients on adalimumab should be screened for latent tuberculosis and other chronic infections before initiation, per the boxed warning shared across the originator and biosimilar labels, and monitored for signs of infection throughout therapy.
Substitution status varies by product. Amjevita and Cyltezo both carry FDA interchangeable designations for defined strengths and presentations, meaning a pharmacist may substitute at the pharmacy level without prescriber sign-off in jurisdictions that recognise the US interchangeability pathway; the exact interchangeable scope has differed by strength and by when each low-concentration or high-concentration formulation received its own designation, so verify against the current FDA list before treating any two SKUs as automatically substitutable.
The documentation pack a regulator actually asks for.
Adalimumab moves through the same biologic cold-chain documentation chain regardless of brand: temperature-logged transport from the Indian dispatch point, continuous 2-8°C validation, and shipment-level time-and-temperature records handed to the buyer's regulatory affairs team for import clearance. M Care authors the CTD/eCTD-format dossier support documentation the destination regulator requires and sources every line through WHO-GMP-audited or EU-GMP-capable partner sites and licensed Indian distribution channels; M Care itself is a merchant exporter and does not hold WHO-GMP, WHO-PQ or manufacturing status, and does not manufacture any product it exports.
On the brand question: Humira remains AbbVie's originator biologic. Amjevita (Amgen) and Cyltezo (Boehringer Ingelheim) are FDA-licensed biosimilars, not generics in the small-molecule sense, each with its own Biologics License Application and its own interchangeability determination for specific strengths. Buyers choosing between the originator and a biosimilar should base the decision on the destination market's own regulatory recognition of that specific biosimilar, since a US FDA licence does not by itself confer marketing authorisation in the GCC, Africa or the EU.
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 adalimumab.
Etanercept
Another allergy & immunology line ordered on the same formularies.
Infliximab
Another allergy & immunology line ordered on the same formularies.
Levocetirizine
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 adalimumab.
- 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.
Adalimumab supply, the specific questions.
Is there a generic version of Humira?
Adalimumab is a biologic, so there is no small-molecule generic. What exists instead are FDA-licensed biosimilars, including Amjevita and Cyltezo, each approved on its own Biologics License Application rather than as a copy of Humira's chemical structure.
Are Amjevita and Cyltezo interchangeable with Humira?
Both carry FDA interchangeable designations, but the scope has built up strength by strength and, for Cyltezo, low-concentration and high-concentration formulation by formulation. Confirm the interchangeable status against the current FDA list for the exact strength being ordered, not assumed across the whole product line.
How is adalimumab shipped and stored during export?
As a biologic, adalimumab is cold-chain throughout: continuous 2-8°C from the manufacturing site to the point of administration, with temperature logging on every leg of transport. It must never be frozen. M Care ships it only on cold-chain validated lanes with shipment-level temperature records for the buyer's import file.
Can M Care supply Humira to my market?
M Care sources Humira, Amjevita and Cyltezo through licensed Indian distribution channels and can quote against your specification. Final import basis depends on your market's own regulatory recognition of the specific brand or biosimilar, which the Mumbai desk will confirm against your destination country's requirements before quoting.
What indications is adalimumab licensed for?
The FDA label covers rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and non-infectious uveitis, with dosing that varies significantly by indication. Buyers should confirm the exact approved indication set against their own destination-country labelling.
Does the dosing schedule differ between Humira and its biosimilars?
The approved dosing regimens are matched to Humira's label since biosimilars are required to demonstrate no clinically meaningful difference. The presentation (pen versus prefilled syringe) and available strengths can differ by product, which matters for patient training and formulary stocking decisions.
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.