LIBTAYO 350 MG / 7 ML — DIN 02487144
CEMIPLIMAB : 350 MG / 7 ML · REGENERON CANADA COMPANY · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is LIBTAYO?
LIBTAYO 350 MG / 7 ML contains CEMIPLIMAB : 350 MG / 7 ML. It is listed in the Health Canada Drug Product Database under DIN 02487144, held by REGENERON CANADA COMPANY, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 07-Apr-2025. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is LIBTAYO used for?
Treatment of adults with metastatic/locally advanced CSCC; first-line NSCLC (monotherapy if PD-L1 ≥ 50% or with chemotherapy); locally advanced BCC after HHI; and recurrent/metastatic cervical cancer.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Cemiplimab cost around the world?
Cemiplimab is listed on 7 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Czechia publishes a max producer price (ex-factory); Greece publishes a producer price (ex-factory). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Australia | ex-manufacturer | 1 | 8 | AUD███.██ |
| Norway | max AUP (pharmacy retail) | 1 | 3 | NOK███.██ |
| Czechia | max producer price (ex-factory) | 1 | 1 | CZK███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
| Italy | ex-factory (classe H) | 1 | 1 | EUR███.██ |
| Romania | max producer price | 1 | 1 | RON███.██ |
| Slovakia | categorised final price | 1 | 1 | EUR███.██ |
16 pack listings across 7 brand entries and 7 price bases, refreshed 08 Sep 2026. Ranges span every Cemiplimab pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Cemiplimab in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
2 holders have a Canadian DIN containing Cemiplimab, across 2 DINs, of which 1 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| REGENERON CANADA COMPANY | 1 | 1 | LIBTAYO | Sourceable in Canada |
| SANOFI-AVENTIS CANADA INC | 1 | 0 | LIBTAYO | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 350 MG / 7 ML |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | 10 mL single-use glass vial containing 350 mg cemiplimab (50 mg/mL). The vial has a 20 mm grey chlorobutyl elastomeric stopper and a violet flip-off button. |
| Storage | Store vials under refrigeration at 2°C to 8°C. Do not freeze. Store in original carton to protect from light. Diluted solution: up to 8h at room temp or 10 days at 2-8°C. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Cemiplimab |
|---|---|
| ATC code | L01FF06 |
| AHFS class | 10:00.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02487144 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2487144 |
| Brand name | LIBTAYO |
| Generic / active ingredient | CEMIPLIMAB : 350 MG / 7 ML |
| Market authorization holder | REGENERON CANADA COMPANY |
| Health Canada schedule | Schedule D |
| ATC code | L01FF06 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01FF |
| Current status | MARKETED |
| Status date | 07-Apr-2025 |
| Original market date | 2019-05-24 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
350 mg every 3 weeks administered as an intravenous infusion over 30 minutes. Treatment continues until disease progression or unacceptable toxicity (96 weeks for cervical cancer).
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to cemiplimab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Severe and fatal immune-mediated adverse reactions can occur in any organ system. Monitor for pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and severe skin reactions (SJS/TEN).
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
1 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| LIBTAYO | 250 MG / 5 ML | SOLUTION | SANOFI-AVENTIS CANADA INC | CANCELLED POST MARKET | 02487152 |
2 · Same class — other molecules in ATC L01FF
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Nivolumab | OPDIVO · OPDIVO SC | 3 | 3 | Yes |
| Atezolizumab | TECENTRIQ · TECENTRIQ SC | 3 | 3 | Yes |
| Cemiplimab | LIBTAYO | 2 | 1 | Yes |
| Pembrolizumab | KEYTRUDA | 2 | 1 | Yes |
| Retifanlimab | ZYNYZ | 1 | 1 | Yes |
| Avelumab | BAVENCIO | 1 | 1 | Yes |
| Dostarlimab | JEMPERLI | 1 | 1 | Yes |
| Durvalumab | IMFINZI | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC L01F
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01FX | Amivantamab · Belantamab Mafodotin · Blinatumomab · Brentuximab Vedotin · Catumaxomab · +19 more | 36 | 29 |
| L01FD | Pertuzumab · Trastuzumab · Trastuzumab Deruxtecan · Trastuzumab Emtansine | 18 | 16 |
| L01FG | Bevacizumab · Ramucirumab | 14 | 14 |
| L01FA | Obinutuzumab · Ofatumumab · Rituximab | 11 | 8 |
| L01FC | Daratumumab · Isatuximab | 5 | 5 |
| L01FY | Nivolumab And Relatlimab · Pertuzumab And Trastuzumab | 4 | 4 |
| L01FE | Cetuximab · Necitumumab · Panitumumab | 5 | 3 |
| L01FB | Inotuzumab Ozogamicin | 1 | 1 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.