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Linvoseltamab-gcpt bulk supplier for pharma manufacturers

Linvoseltamab-Gcpt 5 mg/2.5 mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 5 mg/2.5 mL

Reference Brands: Lynozyfic (USA/EU)

Category: Oncology Cancer Care

Linvoseltamab‑gcpt is a bispecific T‑cell engager antibody that binds to CD3 on T‑cells and BCMA on malignant plasma (myeloma) cells. This facilitates T‑cell activation and directs T cells to kill multiple myeloma cells. Lynozyfic is indicated for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including a proteasome inhibitor, im‑modulatory agent and an anti‑CD38 antibody).

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Product Description:

Linvoseltamab is a bispecific antibody that links CD3 on a T cell to BCMA on a myeloma cell. BCMA is a near-ideal target: it is expressed on malignant plasma cells and almost nowhere else, which is why it has become the focus of the newest myeloma therapies. Unlike CAR-T approaches directed at the same antigen, this is an off-the-shelf product requiring no cell collection, no manufacturing slot and no bridging therapy while a patient waits.

It is indicated for relapsed or refractory multiple myeloma in adults who have had at least four prior lines including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody — a population with very limited options. It is given intravenously with a step-up schedule to mitigate cytokine release syndrome, which occurs in a majority of patients and is usually confined to the first cycle. Neurotoxicity, serious infection and prolonged hypogammaglobulinaemia requiring immunoglobulin replacement also occur.

Sourcing notes. Originator biologic under patent, recently approved and not yet registered everywhere — confirm status per destination. Cold chain at 2–8 degrees, do not freeze or shake. The receiving centre must be able to monitor inpatients through the step-up doses.

How Linvoseltamab-Gcpt is supplied today, and licensing ahead of patent expiry

Where linvoseltamab is approved

Checked 3 Oct 2026
MarketStatusBrand · regulator · date
European Union Approved Lynozyfic · European Commission · Apr 2025 (conditional)
United States Approved Lynozyfic · FDA · Jul 2025
Generic / biosimilar None None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access
Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing
A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives
Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule
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Frequently Asked Questions

Linvoseltamab‑gcpt is used to treat adults with relapsed or refractory multiple myeloma, particularly those who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.

It is a bispecific T‑cell engaging antibody produced in cell culture, designed to bind CD3 on T‑cells and B‑cell maturation antigen (BCMA) on multiple myeloma cells, directing T‑cells to kill the cancer cells.

The trade name is Lynozyfic.

It is manufactured by Regeneron Pharmaceuticals, Inc.

The generic name is linvoseltamab‑gcpt.

The brand name is Lynozyfic.

It is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cell culture and formulated as a sterile intravenous drug.

Lynozyfic (Linvoseltamab) is developed and sold by Regeneron. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.

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