Romosozumab bulk supplier for pharma manufacturers

Romosozumab 105 mg/1.17 mL Suppliers & Bulk Manufacturers

Available Forms: injection (prefilled syringe)

Available Strengths: 105 mg/1.17 mL

Reference Brands: Evenity (USA/EU)

Romosozumab is a monoclonal antibody used for the treatment of osteoporosis in postmenopausal women and men at high risk of fracture. It works by inhibiting the protein sclerostin, which increases bone formation and decreases bone resorption. Romosozumab is administered as a monthly subcutaneous injection and helps improve bone density and reduce fracture risk.

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Product Description:

Romosozumab is a monoclonal antibody against sclerostin, a protein secreted by osteocytes that acts as the body's brake on bone formation. Blocking it produces an effect no other osteoporosis drug achieves: bone formation rises and resorption falls at the same time. Every other agent does one or the other. That dual action produces gains in bone density substantially larger than bisphosphonates deliver, but the effect is self-limiting and fades after about a year as the system adapts.

It is used for osteoporosis in postmenopausal women and men at high risk of fracture, given as two subcutaneous injections once monthly for twelve months only, after which an antiresorptive must follow or the gains are lost. It carries a boxed warning for myocardial infarction, stroke and cardiovascular death, and is contraindicated in anyone who has had a heart attack or stroke in the preceding year — a genuine limitation in the elderly population that needs it. Hypocalcaemia must be corrected first.

Sourcing notes. Originator biologic, on patent. The fixed twelve-month course makes per-patient demand predictable and finite. Cold chain at 2–8 degrees, protect from light, do not freeze or shake; it may be held at room temperature for a limited period before use. Two syringes constitute one dose.

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

Romosozumab 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 Romosozumab, 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

Romosozumab is used to treat osteoporosis in postmenopausal women and men at high risk of fracture.

Romosozumab is made from a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein that limits bone formation.

The trade name of Romosozumab is Evenity.

Romosozumab is made by Amgen Inc. and UCB Pharma.

The generic name of the product is Romosozumab.

The brand name of Romosozumab is Evenity.

Romosozumab is manufactured by Amgen Inc. in the United States and also by UCB Pharma in Belgium.

Evenity (Romosozumab) is developed and sold by Amgen and UCB. 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.