Counterfeit versions of Keytruda, a critically important cancer immunotherapy, have been detected within India-linked supply chains. This alarming development comes years before the drug's patent is set to expire, raising serious concerns about patient safety and the integrity of the pharmaceutical distribution network.
Early Arrival of Falsified Oncology Drugs
Keytruda, developed by MSD, is a top-selling prescription drug globally, used to treat various cancers including lung cancer, melanoma, and head and neck cancers. Its patents are expected to expire between 2028 and 2030, opening a significant opportunity for Indian companies like Biocon, Dr. Reddy’s Laboratories, and Cipla to introduce biosimilar versions. However, the premature appearance of fake Keytruda in the market, well before any legal biosimilars are available, points to critical gaps in enforcement and distribution.
Dr. Rashmi Chaturvedi Upadhyay, founder and chief strategy officer at ProVanta Life Tech, noted that Keytruda’s global sales are around $25 billion, with a projected biosimilar opportunity of $10–15 billion. She anticipates a gradual, rather than sharp, impact on the drug’s market even after biosimilar entry.
India's High Demand, Limited Access Challenge
India faces a substantial cancer burden, with 1.4–1.5 million new cases annually and over 3 million people living with the disease. The country's oncology drug market is valued at $2.5–3 billion, growing at over 12% per year. Despite this growing market and pipeline activity for new cancer therapies, access to advanced treatments like Keytruda remains highly uneven.
A single dose of pembrolizumab (the active ingredient in Keytruda) can cost between Rs 2–4 lakh in India, with a full course running into tens of lakhs. Such high costs render these life-saving therapies unaffordable for many patients who primarily rely on out-of-pocket spending. While the government has reduced customs duties on some imported cancer drugs, high-value biologics like Keytruda often see limited benefit, leaving pricing as a major barrier.
How Counterfeit Drugs Enter the Market
The significant gap between high demand and limited affordability creates an ideal environment for counterfeit drugs to thrive. These falsified products typically enter through informal distribution networks, unauthorized imports, or diversion at the distributor level, especially for high-value therapies where profit margins are substantial.
Global alerts underscore the severity of the risk. The World Health Organization (WHO) issued a Medical Product Alert in November 2024, warning that falsified Keytruda products “pose a significant risk to public health,” as patients may receive “no therapeutic benefit.” International cases have linked India to this global counterfeit trade; for instance, US authorities recently sentenced an Indian national for trafficking counterfeit Keytruda that contained no active ingredient, described as “just like water.”
A Precedent: The Ozempic Case
This pattern of early counterfeit circulation before patent expiry is not unprecedented. Ozempic, a Novo Nordisk drug, also saw falsified versions appear across multiple countries well before its patent ended. These products, often distributed via online platforms and unauthorized sellers, targeted patients seeking weight-loss treatments. Regulators reported incorrect ingredients, substituted compounds, or unsafe formulations, leading to serious health risks for patients.
The parallels between Keytruda and Ozempic are clear: both are high-value, high-demand therapies with strong clinical outcomes but restricted access due to pricing. In both instances, counterfeits infiltrated the market while the original products were still under patent protection, highlighting a vulnerability in supply chains when demand is high and access is constrained.
Regulatory Response and Future Outlook
In response to global alerts, India's drug regulator, the Drugs Controller General of India (DCGI), has instructed state authorities to enhance surveillance. This includes testing suspicious batches, monitoring distributors, and taking action against unauthorized sales. Manufacturers like Takeda Pharmaceutical Company have also issued warnings, advising procurement “only through authorised distribution channels” for their oncology drug Adcetris.
As Indian companies prepare for the significant biosimilar opportunity that will emerge when patents on drugs like Keytruda expire, the current infiltration of counterfeits presents a critical test for supply chain integrity. Biosimilars are expected to enter the market at significantly lower prices, typically 30–60% below originator biologics, which will be crucial for expanding access to life-saving cancer therapies.