Ocrelizumab Injection 300 mg Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 300 mg

Reference Brands: Ocrevus(EU & US)

Category: Multiple sclerosis

Ocrelizumab 300 mg/10 mL concentrate for intravenous infusion, an anti-CD20 antibody for relapsing and primary progressive multiple sclerosis, for hospital pharmacies, importers and specialist distributors.

Product Description:

Ocrelizumab is a humanised monoclonal antibody against CD20, a marker on most B cells. Binding CD20 depletes these cells and damps the immune activity behind multiple sclerosis, while plasma cells and stem cells, which lack CD20, keep working. This product is a 300 mg in 10 mL concentrate, diluted in sodium chloride 0.9% for slow intravenous infusion in a hospital or infusion centre. One vial makes each of the first two half-doses two weeks apart; then two vials make each six-monthly 600 mg dose.

It is used for relapsing and primary progressive multiple sclerosis. Hepatitis B screening is required first, and it is not started during active infection. Each infusion follows methylprednisolone and an antihistamine, often with an antipyretic, because infusion reactions are common, and patients are observed for at least an hour afterwards. Live vaccines are not given during treatment, and other vaccines are ideally completed before starting. Immunoglobulin levels, infections and rare progressive multifocal leukoencephalopathy are part of the monitoring plan.

Sourcing notes. Ocrelizumab is a prescription-only biological medicine for specialist use. Vials need an unbroken 2-8 °C cold chain, in the carton away from light and never frozen, so ask for temperature logger data with each shipment. A non-originator product must be approved as a biosimilar in the destination market, so confirm the registration route before quoting. Request the CTD dossier, CoA and release papers per batch, the biologics GMP certificate and a CoPP, and state vial numbers and required shelf life.