Guselkumab Injection bulk supplier for pharma manufacturers

Guselkumab Injection Suppliers & Bulk Manufacturers

Available Forms: Pre-filled syringe, pen (subcutaneous); vial (IV infusion)

Available Strengths: 100 mg/mL, 200 mg/2 mL (SC); 200 mg/20 mL (IV)

Pack Sizes: 1 pre-filled syringe or pen; 1 vial

Reference Brands: Tremfya (Johnson & Johnson)

Guselkumab (Tremfya, Johnson & Johnson) is an IL-23 blocking antibody for plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease. After the first doses it is usually injected every eight weeks. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

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Product Description:

Guselkumab is a monoclonal antibody that binds the p19 subunit of interleukin-23 (IL-23). IL-23 keeps a group of inflammatory T cells active in the skin, joints and gut. Blocking only the p19 subunit targets this pathway more selectively than ustekinumab, which blocks both IL-12 and IL-23.

It is approved for moderate to severe plaque psoriasis, active psoriatic arthritis and, more recently, moderately to severely active ulcerative colitis and Crohn's disease. For skin and joint disease it is given as a 100 mg injection under the skin at weeks 0 and 4 and then every eight weeks. For the bowel conditions, treatment starts with intravenous or subcutaneous induction doses before maintenance injections.

Sourcing notes. Guselkumab is patented and there is no biosimilar. Enquiries usually come from importers and hospitals using named-patient or special-import routes where it is not registered or is in short supply. It needs cold-chain shipping. Ustekinumab and its biosimilars, and risankizumab, are also listed on PharmaTradz.

How Guselkumab Injection is supplied today, and licensing ahead of patent expiry

Guselkumab Injection 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 Guselkumab Injection, 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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