Certolizumab Pegol 200mg Suppliers & Bulk Manufacturers

Available Forms: injection (prefilled syringe)

Available Strengths: 200mg

Reference Brands: Cimzia (USA/EU)

Category: Immune Disorder

Certolizumab pegol is a PEGylated (polyethylene‐glycol) Fab′ fragment of a humanized anti-TNF-α monoclonal antibody that lacks the Fc portion. It works by binding to tumour necrosis factor-alpha (TNF-α) and neutralising its inflammatory effects, thereby reducing immune-mediated inflammation in various autoimmune conditions.

Product Description:

Certolizumab pegol is a TNF inhibitor built differently from the rest of its class: it is a Fab' antibody fragment attached to polyethylene glycol, with no Fc region. The PEG gives it a long half-life despite the missing Fc, and the absent Fc has two consequences — it does not cause antibody-dependent cell-mediated cytotoxicity or complement activation, and it is not actively transported across the placenta.

It is used for rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and Crohn's disease. The placental point is its distinguishing clinical advantage: in inflammatory disease, which often affects women of childbearing age, other TNF inhibitors cross the placenta in the third trimester and reach high levels in the infant, affecting live vaccination schedules. Certolizumab transfers minimally, so it can generally be continued through pregnancy. Class risks apply: serious infection, tuberculosis reactivation requiring screening, hepatitis B reactivation, and a warning on malignancy.

Sourcing notes. Originator biologic. No biosimilar has been approved, unlike adalimumab and infliximab, so this remains originator-only supply through authorised distribution. Cold chain, with a defined period permitted at room temperature. Prefilled syringe and autoinjector are separate presentations.