Satralizumab bulk supplier for pharma manufacturers

Satralizumab 120mg Suppliers & Bulk Manufacturers

Available Forms: injection (prefilled syringe)

Available Strengths: 120mg

Reference Brands: ENSPRYNG (USA/EU)

Category: Neurology

Satralizumab is a humanized monoclonal antibody that targets the interleukin-6 (IL-6) pathway to reduce inflammatory activity in neuromyelitis optica spectrum disorder (NMOSD). It is indicated (as monotherapy or with immunosuppressants) for AQP4-antibody positive adults with NMOSD and is given by subcutaneous injection (loading doses at Weeks 0, 2, 4, then every 4 weeks maintenance). The approved commercial name in the US, EU and UK is ENSPRYNG and the licensed presentation is a single-use 120 mg/1 mL prefilled syringe. Common important safety notes include an increased risk of serious infections; screening for infections (including hepatitis B / TB) and vaccination status should be reviewed before starting therapy.

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Product Description:

Satralizumab is a humanised monoclonal antibody against the interleukin-6 receptor, engineered as a "recycling" antibody. Its antigen binding is pH-dependent, so it releases IL-6 receptor inside the acidic endosome and returns to the circulation to bind again, which gives it a long enough half-life for monthly subcutaneous dosing. IL-6 drives production of the aquaporin-4 autoantibodies that damage astrocytes in neuromyelitis optica spectrum disorder, and supports the plasmablasts that make them.

It is used to prevent relapses of NMOSD in patients who are anti-aquaporin-4 antibody-positive, either alone or with immunosuppressive therapy. In trials it reduced relapses substantially in seropositive patients, but showed no clear benefit in seronegative disease, so antibody status determines eligibility. Loading doses are given at weeks 0, 2 and 4, then every four weeks. Infection risk rises, hepatitis B and tuberculosis are screened for before starting, and liver enzymes and neutrophils are monitored.

Sourcing notes. Originator biologic, on patent, no biosimilar. Supplied as a prefilled syringe needing refrigeration. It competes with complement inhibitors and anti-CD19 therapy in NMOSD, and its advantage in many markets is home self-injection rather than infusion. Aquaporin-4 antibody testing must be available. Supply is through authorised distribution.

How Satralizumab is supplied today, and licensing ahead of patent expiry

Satralizumab is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Satralizumab, hold a dossier for it or want to license it, talk to us.

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

Satralizumab is used to treat neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune condition that affects the optic nerves and spinal cord. It helps reduce inflammation and prevent relapses by blocking the interleukin-6 (IL-6) receptor, which plays a key role in the immune system’s inflammatory response.

Satralizumab is made from Satralizumab-mwge, a humanized monoclonal antibody that specifically targets the IL-6 receptor to control immune system overactivity.

The trade name of Satralizumab is Enspryng.

Satralizumab (Enspryng) is developed and manufactured by Chugai Pharmaceutical Co., Ltd., a member of the Roche Group, and marketed by Genentech in various countries.

The generic name of Satralizumab is Satralizumab-mwge.

The brand name of Satralizumab is Enspryng.

Satralizumab is manufactured in Japan and Switzerland by Chugai Pharmaceutical and Roche, and distributed globally under regulatory approvals for NMOSD treatment.

Enspryng (Satralizumab) is developed and sold by Roche / Chugai. 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.