OTULFI (Ustekinumab-aauz) Injection

OTULFI (ustekinumab-aauz), from Fresenius Kabi, is a biosimilar to Stelara, indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease and ulcerative colitis in adult patients.

Ustekinumab-aauz is a monoclonal antibody that targets the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23), blocking their interaction with immune cell receptors and reducing the inflammatory cascade underlying these autoimmune conditions.

• Increased risk of infections, including serious bacterial, fungal, and viral infections — screen for tuberculosis before starting treatment.
• Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported rarely.
• Malignancies have been reported in clinical trials; discuss risk factors with your physician.
• Serious hypersensitivity reactions, including anaphylaxis, may occur.

What documents are required to import OTULFI to India?

OTULFI may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered dermatologist/rheumatologist/gastroenterologist as applicable
• Diagnostic report confirming the relevant condition
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is OTULFI available in India?

OTULFI is not commercially marketed in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source OTULFI from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For OTULFI cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA — October 2024 (biosimilar to Stelara).

What is OTULFI used for?

OTULFI treats plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis in adults.

Who manufactures OTULFI?

OTULFI is manufactured by Fresenius Kabi as a biosimilar to Stelara (ustekinumab).

How is OTULFI administered?

By subcutaneous injection or intravenous infusion (initial dose), depending on the indication.

How much does OTULFI cost in India?

Cost depends on dose strength and sourcing logistics — share your prescription with IPN for a quote.