How India Exports Trastuzumab to the World

In the United States, trastuzumab received its initial approval from the FDA on September 25, 1998, under the brand name Herceptin, for the treatment of metastatic breast cancer in patients whose tumors overexpress the HER2 protein. Since then, the FDA has approved several biosimilar versions of trastuzumab, expanding treatment options and potentially reducing costs. The presence of 179 active Indian exporters underscores the competitive nature of the market, necessitating strict adherence to FDA regulations, including compliance with the Biologics License Application (BLA) pathway for biosimilars.

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for Herceptin on August 28, 2000. (ema.europa.eu) Subsequently, the EMA has approved multiple trastuzumab biosimilars, such as Herzuma (February 9, 2018) and Ontruzant (November 15, 2017), enhancing patient access and fostering market competition. (ema.europa.eu) The United Kingdom, through the Medicines and Healthcare products Regulatory Agency (MHRA), continues to align with EMA standards post-Brexit, ensuring that biosimilars meet stringent quality, safety, and efficacy requirements. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for manufacturers exporting to these regions.

Trastuzumab is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its significance in global health. The WHO Prequalification Programme evaluates biosimilars to ensure they meet international standards, facilitating their adoption in various healthcare systems. Trastuzumab formulations must comply with pharmacopoeial standards, including those set forth in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure consistent quality across different markets.

In India, trastuzumab is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of March 2026, trastuzumab is not listed under the Drug Price Control Order (DPCO), allowing market-driven pricing. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) to ensure compliance with export regulations.

The primary patents for trastuzumab have expired in major markets, leading to increased generic competition and the approval of multiple biosimilars. This shift has contributed to more affordable treatment options and expanded access for patients globally.

In February 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorization for Poherdy, a biosimilar intended for the treatment of breast cancer. (ema.europa.eu) This development reflects the ongoing expansion of biosimilar options in the European market.

In September 2024, the EMA granted marketing authorization for Tuznue, another trastuzumab biosimilar, further diversifying the treatment landscape for HER2-positive cancers. (ema.europa.eu)

These developments underscore the dynamic nature of the trastuzumab market, with regulatory agencies continually evaluating and approving biosimilars to enhance patient access and treatment affordability.

The production of Trastuzumab relies on specific Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). India's pharmaceutical industry has historically depended heavily on imports for these components, particularly from China. In 2024, it was reported that 43% of India's total pharmaceutical imports originated from China, highlighting a significant reliance on Chinese suppliers for APIs and KSMs.

This dependency poses a risk, as any disruptions in the supply chain from China—due to geopolitical tensions, export restrictions, or other factors—can lead to shortages and increased costs for Indian manufacturers. Such vulnerabilities underscore the need for diversification and strengthening of domestic production capabilities to mitigate potential supply chain disruptions.

The export market for Trastuzumab from India is highly concentrated. The top five exporters account for 85.7% of the total export value, with MYLAN LABORATORIES LIMITED alone contributing $47.0 million USD, representing a 60.9% share. This high level of supplier concentration increases the risk of supply disruptions, as issues affecting these key players—such as manufacturing problems, regulatory challenges, or financial difficulties—could significantly impact global availability.

To address such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce reliance on imports. This initiative has led to the revival of large-scale API manufacturing units and investments in advanced technologies, enhancing India's self-sufficiency in pharmaceutical production. (pharmanow.live)

Recent geopolitical events have further strained global supply chains. In March 2026, the closure of the Strait of Hormuz following military actions by the US and Israel led to significant disruptions in maritime trade. This strait is a critical chokepoint through which approximately 20% of the world's oil and natural gas transit. The closure resulted in a sharp decline in tanker traffic and a surge in oil prices, impacting various industries, including pharmaceuticals.

Additionally, the Red Sea and the Strait of Hormuz have experienced increased threats to commercial shipping due to regional conflicts, further complicating logistics and increasing transportation costs. These disruptions can lead to delays in the delivery of raw materials and finished pharmaceutical products, affecting the timely availability of medications like Trastuzumab.

To enhance the resilience of the Trastuzumab supply chain, the following actions are recommended:

• Diversify API and KSM Sources: Reduce dependency on a single country by establishing alternative suppliers in different regions to mitigate risks associated with geopolitical tensions and export restrictions.

• Strengthen Domestic Manufacturing: Leverage initiatives like the PLI scheme to boost local production of APIs and KSMs, decreasing reliance on imports and enhancing self-sufficiency.

• Expand Supplier Base: Encourage the development of additional manufacturers to reduce the high concentration among a few exporters, thereby minimizing the impact of potential disruptions from any single supplier.

• Enhance Logistics Planning: Develop contingency plans for shipping routes and transportation methods to navigate geopolitical disruptions, ensuring the continuous flow of raw materials and finished products.

• Monitor Regulatory Developments: Stay informed about international regulatory changes and potential sanctions that could affect trade routes and supplier relationships, allowing for proactive adjustments to the supply chain strategy.

RISK_LEVEL: HIGH