How India Exports Ustekinumab to the World

As of March 2026, the FDA has not approved any Abbreviated New Drug Applications (ANDAs) for ustekinumab, indicating no generic versions are available in the U.S. market. The original Biologics License Application (BLA) for ustekinumab was approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The regulatory pathway for biologics like ustekinumab involves a BLA submission, requiring comprehensive clinical data to demonstrate safety and efficacy. Given the absence of approved generics, Indian exporters must navigate stringent FDA regulations, including compliance with Good Manufacturing Practices (GMP) and potential pre-approval inspections, to access the U.S. market.

In the European Union, the European Medicines Agency (EMA) has approved several ustekinumab-containing products. For instance, Usrenty received marketing authorization on 17 September 2025 for treating plaque psoriasis, psoriatic arthritis, and Crohn's disease. Similarly, Usgena was authorized on 17 November 2025 for similar indications. Manufacturers exporting to the EU and UK must adhere to EMA and Medicines and Healthcare products Regulatory Agency (MHRA) guidelines, including obtaining marketing authorization and complying with EU Good Manufacturing Practice (GMP) standards. These standards ensure product quality and safety, necessitating rigorous quality control measures and regular inspections.

Ustekinumab is not listed in the World Health Organization's (WHO) Model List of Essential Medicines as of March 2026. Consequently, it has not undergone WHO Prequalification, a program that assesses the quality, safety, and efficacy of medicinal products. However, ustekinumab must comply with international pharmacopoeia standards, including those set by the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Adherence to these standards ensures the medicine's quality and facilitates its acceptance in various global markets.

In India, ustekinumab is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for its dispensation. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for ustekinumab as of March 2026, allowing market-driven pricing. For export purposes, the Central Drugs Standard Control Organization (CDSCO) mandates a No Objection Certificate (NOC), ensuring that the export does not affect domestic availability and complies with regulatory standards.

Ustekinumab's primary patents have expired in several jurisdictions, leading to the development and approval of biosimilars. For example, the EMA approved Usrenty on 17 September 2025 and Usgena on 17 November 2025 as biosimilars to the reference product Stelara. This increased competition may influence market dynamics and pricing strategies for Indian exporters.

In February 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorization for Stelara, expanding its indication to include the treatment of moderately to severely active Crohn’s disease in pediatric patients from the age of 2 years and older. This expansion may increase the demand for ustekinumab in the European market.

In September 2025, the EMA granted marketing authorization for Usrenty, a biosimilar of ustekinumab, for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease. This approval introduces additional competition in the European market, potentially affecting market share and pricing for existing products.

In November 2025, the EMA approved Usgena, another biosimilar of ustekinumab, further intensifying competition in the European market. The entry of multiple biosimilars may lead to price reductions and increased accessibility for patients.

In August 2025, the European Commission withdrew the marketing authorization for Eksunbi, a ustekinumab product, at the request of the marketing authorization holder, Samsung Bioepis NL B.V., due to commercial reasons. This withdrawal may impact the availability of certain ustekinumab products in the EU market.

In December 2025, the European Commission withdrew the marketing authorization for Absimky, another ustekinumab product, at the request of the marketing authorization holder, Accord Healthcare S.L.U., also due to commercial reasons. Such withdrawals may influence market dynamics and present opportunities for other manufacturers.

These developments underscore the evolving regulatory and competitive landscape for ustekinumab, highlighting the importance for Indian exporters to stay informed and adapt to changing market conditions.

Ustekinumab, a monoclonal antibody used in the treatment of various inflammatory conditions, relies on complex manufacturing processes involving specific Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). India, a significant producer of APIs, has historically depended on China for a substantial portion of its KSMs. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in this sector. This dependency exposes Indian pharmaceutical manufacturers to supply chain vulnerabilities, particularly when Chinese suppliers face operational disruptions.

In recent years, environmental regulations in China have led to the shutdown of numerous chemical factories, directly impacting the availability and cost of KSMs. For instance, over the last year, nearly 1.5 lakh factories in China have closed down, of which a quarter will affect pharmaceuticals. An estimated 145 API manufacturers have shut shop there. Such disruptions have resulted in significant price hikes for essential materials, with some experiencing increases of up to 484%. These supply chain interruptions underscore the risks associated with heavy reliance on a single country for critical raw materials.

Analysis of TransData Nexus's proprietary trade data from 2022 to 2026 reveals that the top five Indian exporters of Ustekinumab account for 70.8% of the total export value, indicating a high supplier concentration. NIVIRA EXPORTS leads with a 23.6% share, followed by GNH INDIA PHARMACEUTICALS LIMITED (18.9%), BIOCON BIOLOGICS INDIA LIMITED (12.6%), VAMA LIFECARE PRIVATE LIMITED (9.9%), and R B INTERNATIONAL (5.9%). This concentration poses a single-source risk, as disruptions affecting these key suppliers could significantly impact the global supply of Ustekinumab.

To mitigate such risks, the Indian government has introduced the Production-Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce dependency on imports. However, the effectiveness of this initiative in diversifying the supplier base for Ustekinumab remains to be fully realized. Continued monitoring and strategic planning are essential to address potential vulnerabilities arising from supplier concentration.

Recent geopolitical tensions have significantly disrupted global shipping routes, impacting pharmaceutical exports from India. The US-Israel-Iran conflict, which escalated in February 2026, led to the closure of critical logistics hubs in the Middle East, including Dubai International Airport and Jebel Ali Port. These closures have severely affected air cargo transshipments and cold-chain handling, essential for the transportation of temperature-sensitive pharmaceuticals like Ustekinumab.

Additionally, maritime disruptions in key transit corridors such as the Red Sea and the Strait of Hormuz have resulted in increased freight charges and extended transit times. The Pharmaceutical Export Promotion Council of India (Pharmexcil) has projected potential losses of ₹2,500–₹5,000 crore in March 2026 due to these disruptions. Such challenges underscore the need for robust risk management strategies to ensure the uninterrupted supply of critical medications.

• Diversify Supplier Base: Encourage the development of alternative suppliers for APIs and KSMs to reduce dependency on a single country or supplier.

• Enhance Domestic Production: Leverage government initiatives like the PLI scheme to bolster domestic manufacturing capabilities for critical raw materials.

• Strengthen Logistics Infrastructure: Invest in resilient logistics networks, including alternative shipping routes and enhanced cold-chain facilities, to mitigate the impact of geopolitical disruptions.

• Implement Strategic Stockpiling: Maintain buffer inventories of essential materials to cushion against supply chain interruptions.

• Conduct Regular Risk Assessments: Continuously monitor and assess geopolitical developments and their potential impact on the supply chain to proactively address emerging risks.

RISK_LEVEL: HIGH