How India Exports Osimertinib to the World

In the United States, the Food and Drug Administration (FDA) granted initial approval for osimertinib on November 13, 2015, for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR TKI therapy. Subsequent approvals expanded its indications, including adjuvant therapy after tumor resection in adult patients with NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations, approved on December 18, 2020. The most recent approval, dated February 16, 2024, authorized its use in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with specific EGFR mutations.

As of March 2026, the FDA's Orange Book lists one approved Abbreviated New Drug Application (ANDA) for osimertinib tablets, submitted by Alembic Pharmaceuticals Limited. This ANDA received tentative approval on May 31, 2023, indicating that while the generic product meets the necessary requirements, final approval is pending due to existing patent protections or exclusivity periods.

Given the limited number of approved ANDAs, the U.S. market for osimertinib remains predominantly brand-driven. This scenario presents opportunities for Indian exporters, especially considering the 15 active exporters from India and the 50% repeat buyer rate, to establish a foothold in the U.S. market upon the expiration of existing patents and exclusivities.

In the European Union, the European Medicines Agency (EMA) granted a conditional marketing authorization for Tagrisso on February 2, 2016, which was converted to a full marketing authorization on April 24, 2017. The authorization covers the treatment of adults with locally advanced or metastatic NSCLC with specific EGFR mutations. (ema.europa.eu)

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) issued its first authorization under Project Orbis for osimertinib on May 7, 2021. This approval extended the use of osimertinib to include post-surgery treatment for lung cancer, offering a novel option for patients in early-stage disease. (gov.uk)

Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for manufacturers exporting to these regions. Indian exporters must ensure adherence to these standards to maintain market access.

As of March 2026, osimertinib is not listed in the World Health Organization's (WHO) Model List of Essential Medicines. Consequently, it has not undergone WHO Prequalification. However, adherence to international pharmacopoeia standards, such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), is crucial for ensuring product quality and facilitating global trade.

In India, osimertinib is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. As of March 2026, the National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for osimertinib under the Drug Price Control Order (DPCO). Exporting osimertinib from India requires a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations.

Osimertinib is protected by multiple patents, with the primary patent held by AstraZeneca. The exclusivity period for the adjuvant therapy indication, approved on December 18, 2020, extends until December 18, 2027. This exclusivity delays the entry of generic competitors into the market, maintaining AstraZeneca's market dominance.

In July 2022, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended updating the product information for osimertinib to include warnings about cardiac failure, based on data from clinical trials and spontaneous reports. (ema.europa.eu)

In September 2025, the PRAC further recommended updating the product information to include warnings about hepatitis B reactivation, following evidence from EudraVigilance and literature reviews. (ema.europa.eu)

These developments underscore the importance of continuous monitoring and updating of safety information for osimertinib. Indian exporters must stay informed about such regulatory changes to ensure compliance and maintain market access.

In summary, while the global regulatory landscape for osimertinib presents challenges due to patent protections and stringent regulatory requirements, opportunities exist for Indian exporters, particularly in markets like Brazil and the United Kingdom, which account for 56.9% and 24.2% of India's osimertinib exports, respectively. Adherence to international standards and proactive engagement with regulatory updates will be key to capitalizing on these opportunities.

Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) often relies on Key Starting Materials (KSMs) sourced from China. This dependency exposes the supply chain to potential disruptions, as China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply.

Recent environmental regulations in China have led to the shutdown of several chemical manufacturing units, causing supply constraints and price volatility for KSMs. For instance, in July 2018, the closure of Chinese companies impacted Indian pharmaceutical players, leading to increased API prices due to higher KSM costs. Such events underscore the vulnerability of the Osimertinib supply chain to external factors affecting KSM availability.

Our proprietary trade data indicates that the top five Indian exporters account for 60.6% of Osimertinib exports, with NIVIRA EXPORTS leading at a 31.9% share. This concentration poses a single-source risk, as disruptions affecting these key suppliers could significantly impact global supply.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme to promote domestic manufacturing of critical APIs and KSMs. As of March 2025, the scheme has led to import savings of ₹1,362 crore and the establishment of domestic production capacity for 25 identified items. However, the effectiveness of this initiative in diversifying Osimertinib's supplier base remains to be fully realized.

Geopolitical tensions and shipping disruptions pose additional risks to the Osimertinib supply chain. Incidents in critical maritime routes, such as the Red Sea and the Strait of Hormuz, can delay shipments and increase transportation costs. Furthermore, escalating US-China trade tensions may lead to tariffs or export restrictions on pharmaceutical ingredients, affecting the availability and pricing of KSMs essential for Osimertinib production.

Regulatory bodies like the FDA and EMA have previously issued shortage alerts for various pharmaceuticals due to such disruptions. While no specific alerts for Osimertinib have been reported recently, the interconnected nature of global supply chains means that any significant geopolitical event could have cascading effects on drug availability.

• Diversify Supplier Base: Encourage partnerships with multiple API and KSM suppliers across different regions to reduce dependency on a single source.

• Enhance Domestic Production: Leverage the PLI scheme to bolster domestic manufacturing capabilities for Osimertinib's API and KSMs, reducing reliance on imports.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events and assess their potential impact on the supply chain, enabling proactive risk management.

• Strengthen Inventory Management: Maintain strategic stockpiles of critical raw materials and finished products to buffer against supply disruptions.

• Invest in Alternative Shipping Routes: Explore and invest in alternative logistics and shipping routes to mitigate risks associated with traditional maritime channels.

RISK_LEVEL: MEDIUM