Ustekinumab (Stelara) Biosimilars in India: Are They as Effective?
Ustekinumab is one of the more established biologics in international psoriasis treatment, and its patent expiry has triggered a wave of new biosimilars globally. For Indian patients, the picture is more mixed than for a drug like secukinumab — worth understanding clearly before assuming easy local access.
What Is Ustekinumab and How Does It Work?
Ustekinumab, sold internationally as Stelara, is a human monoclonal antibody that targets the p40 protein subunit shared by two cytokines: interleukin-12 (IL-12) and interleukin-23 (IL-23). By blocking this shared component, it interrupts two separate inflammatory pathways at once, which is mechanistically different from the more selective IL-17 or IL-23-only inhibitors covered in our other guides. It was originally approved by the FDA in 2009, making it one of the older biologics still in widespread use for psoriasis.
Is Ustekinumab (or a Biosimilar) Available in India?
The originator product, Stelara, is not commercially registered for open retail sale in India — patients typically access it through a Named Patient Program import route, similar to guselkumab and risankizumab covered elsewhere in this series. Internationally, several FDA-approved ustekinumab biosimilars (such as Steqeyma, Pyzchiva, and Yesintek) have launched at significant discounts — some at 80-90% below Stelara’s list price — as patent protection has expired, though these specific biosimilars are not necessarily the same products available through Indian import channels.
You may also come across domestically listed ustekinumab-containing injectable products through Indian pharmaceutical suppliers. If you’re offered one of these, it’s worth directly asking your pharmacy or facilitator for the product’s specific CDSCO approval or import license status rather than assuming “available in India” automatically means the same regulatory pathway and quality assurance as an internationally approved biosimilar — this is a reasonable, direct question a licensed distributor should be able to answer clearly.
Ustekinumab Dosing
Dosing for ustekinumab is weight-based:
- Patients weighing 100 kg or less: 45 mg at Week 0, Week 4, then every 12 weeks
- Patients weighing more than 100 kg: 90 mg on the same schedule
This works out to just four maintenance injections a year after the two initial loading doses — one of the least frequent dosing schedules of any psoriasis biologic, comparable to risankizumab and tildrakizumab.
How Effective Is Ustekinumab?
In its pivotal trials, roughly 65-75% of patients achieved PASI 75 by week 12, with response typically well-sustained over years of continued treatment given its long real-world track record dating back over a decade. It’s somewhat less potent for complete clearance (PASI 100) than the newer IL-23-selective inhibitors like risankizumab, but its long safety track record and infrequent dosing remain genuine advantages.
Cost Considerations
Internationally, unbranded ustekinumab (accessed through biosimilar competition) has brought prices down substantially compared to the original branded Stelara, which carries a list price of over $25,000 per dose in some markets. For Indian patients accessing the drug through import channels, landed cost will depend heavily on which specific product and facilitator you use, plus import duties — request a specific written quote rather than relying on any online price listing. See our broader cost guide for how to budget realistically for infrequent-dosing biologics like this one.
Who Is Ustekinumab Typically Considered For?
Ustekinumab is approved for moderate-to-severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis in adults and, for psoriasis specifically, children aged 6 and older. Its dual mechanism and long track record make it a reasonable consideration for patients with overlapping inflammatory bowel disease alongside psoriasis, given its approval across both conditions.
Side Effects
Common side effects include upper respiratory infections, headache, fatigue, and injection site reactions. As with other biologics in this class, screening for latent tuberculosis and other active infections is standard before starting.
This article is for general education and does not replace a consultation with a qualified dermatologist. Drug availability, biosimilar status, and import regulations can change; confirm current details directly with your treating doctor or a licensed specialty pharmacy.
