EPKINLY 60 MG — DIN 02542307
EPCORITAMAB : 60 MG · ABBVIE CORPORATION · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is EPKINLY?
EPKINLY 60 MG contains EPCORITAMAB : 60 MG. It is listed in the Health Canada Drug Product Database under DIN 02542307, held by ABBVIE CORPORATION, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 18-Dec-2023. 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 EPKINLY used for?
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), HGBCL, PMBCL, or FLG3b in adults after 2+ lines of systemic therapy and who received or are unable to receive CAR-T therapy.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Epcoritamab cost around the world?
Epcoritamab is listed on 8 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; Bahrain publishes a retail (max); 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 | 6 | AUD███.██ |
| United Arab Emirates | public | 2 | 2 | AED███.██ |
| Bahrain | retail (max) | 1 | 2 | BHD███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Iceland | max wholesale | 1 | 2 | ISK███.██ |
| Italy | ex-factory (classe H) | 2 | 2 | EUR███.██ |
| Romania | max producer price | 2 | 2 | RON███.██ |
| Saudi Arabia | public | 1 | 2 | SAR███.██ |
20 pack listings across 12 brand entries and 7 price bases, refreshed 08 Sep 2026. Ranges span every Epcoritamab 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 Epcoritamab 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.
Only one market authorization holder has a Canadian DIN containing Epcoritamab — 2 DINs, of which 2 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| ABBVIE CORPORATION | 2 | 2 | EPKINLY | Sourceable in Canada |
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 | 60 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | SUBCUTANEOUS |
| Pack configuration (monograph) | 4 mg/0.8 mL (5 mg/mL) vial with light blue cap; 48 mg/0.8 mL (60 mg/mL) vial with orange cap. Single-dose glass vials. |
| Storage | Store in refrigerator at 2°C to 8°C. Keep in outer carton to protect from light. Do not freeze. Do not shake. |
| 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.
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 | Epcoritamab |
|---|---|
| ATC code | L01FX27 |
| 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) | 02542307 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2542307 |
| Brand name | EPKINLY |
| Generic / active ingredient | EPCORITAMAB : 60 MG |
| Market authorization holder | ABBVIE CORPORATION |
| Health Canada schedule | Prescription |
| ATC code | L01FX27 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01FX |
| Current status | MARKETED |
| Status date | 18-Dec-2023 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Subcutaneous injection in 28-day cycles. Step-up dosing: Day 1 (0.16 mg), Day 8 (0.8 mg), then full dose Day 15 (48 mg). Weekly for Cycles 1-3, then bi-weekly Cycles 4-9, then every 4 weeks.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to epcoritamab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
Warnings and precautions
Serious Warnings: Cytokine Release Syndrome (CRS), ICANS, Progressive Multifocal Leukoencephalopathy (PML), and Haemophagocytic lymphohistiocytosis (HLH). Monitor for 24h after first 48mg dose.
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
2 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| EPKINLY | 5 MG | SOLUTION | ABBVIE CORPORATION | MARKETED | 02542293 |
2 · Same class — other molecules in ATC L01FX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Polatuzumab Vedotin | POLIVY | 2 | 2 | Yes |
| Teclistamab | TECVAYLI | 2 | 2 | Yes |
| Belantamab Mafodotin | BLENREP | 2 | 2 | Yes |
| Glofitamab | COLUMVI | 2 | 2 | Yes |
| Talquetamab | TALVEY | 2 | 2 | Yes |
| Tarlatamab | IMDELLTRA | 2 | 2 | Yes |
| Elranatamab | ELREXFIO | 2 | 2 | Yes |
| Enfortumab Vedotin | PADCEV | 2 | 2 | Yes |
| Epcoritamab | EPKINLY | 2 | 2 | Yes |
| Blinatumomab | BLINCYTO | 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 |
|---|---|---|---|
| L01FD | Pertuzumab · Trastuzumab · Trastuzumab Deruxtecan · Trastuzumab Emtansine | 18 | 16 |
| L01FG | Bevacizumab · Ramucirumab | 14 | 14 |
| L01FF | Atezolizumab · Avelumab · Cemiplimab · Dostarlimab · Durvalumab · +3 more | 14 | 12 |
| 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.
What else is EPKINLY called?
Also recorded in Canada as: 0.8 ML epcoritamab-bysp 60 MG/ML Injection [Epkinly] (US), 0.8 ML epcoritamab-bysp 5 MG/ML Injection [Epkinly] (US), 0.8 ML epcoritamab-bysp 60 MG/ML Injection (US), 0.8 ML epcoritamab-bysp 5 MG/ML Injection (US), EPCORITAMAB-BYSP (US), TEPKINLY (EU), TEPKINLY (UK), EPCORITAMAB (GLOBAL).
The same molecule, Epcoritamab, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Tepkinly | Latin | Bahrain, Iceland, Saudi Arabia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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.