Keytruda, known scientifically as pembrolizumab, is a leading immunotherapy drug that has established itself as a crucial option for treating numerous hard-to-manage cancers. Despite its recent approval by the US Food and Drug Administration (FDA) for a particular type of ovarian cancer, the majority of Indian cancer patients are unable to access this potentially life-saving treatment. The disparity in availability highlights significant economic barriers rather than scientific limitations.

Each year, over 1.5 million new cancer cases are reported in India, with more than 900,000 fatalities linked to various cancers. Yet, fewer than three per cent of patients can currently access novel immunotherapy treatments like Keytruda, which have been shown to enhance survival rates and improve quality of life.

Dr K M Gopakumar, a legal scholar associated with Third World Network, stated that the existing high costs are a major hurdle. The price of pembrolizumab could remain prohibitive for another two years, largely attributed to the drug’s ongoing patent protection.

Significance of Pembrolizumab in Cancer Treatment

Since its initial approval in 2014, pembrolizumab has become integral to the care of various malignancies, including lung, skin, bladder, and kidney cancers. Its inclusion in the World Health Organisation’s Model List of Essential Medicines in September 2025 further underscores its status as a vital therapeutic option. The drug operates by enhancing the immune response against cancer cells, marking a significant shift from traditional treatment methods like chemotherapy.

The global demand for pembrolizumab reflects its effectiveness, making it the world’s best-selling cancer therapy, with annual sales in the tens of billions of dollars. In wealthier nations, it has significantly altered expectations regarding cancer treatment outcomes.

However, for many patients in India, accessing this treatment remains a distant goal. A complete course of pembrolizumab can reach up to Rs 50 lakh, translating to approximately Rs 1.2 crore per year for ongoing treatment. These figures place the therapy beyond the financial reach of the majority of Indian households, which typically rely on out-of-pocket healthcare expenditures.

Future of Access Post-2028

The cost of pembrolizumab is further exacerbated by its patent, held by Merck & Co, which prevents the introduction of more affordable alternatives until June 2028. This situation keeps prices high and limits competition, which is essential for improving drug affordability.

While the possibility of compulsory licensing exists—allowing the government to produce generics in health emergencies—this option has seldom been exercised in India, particularly for high-profile medications like pembrolizumab.

Experts believe that once the patent expires in 2028, the market will likely see the introduction of biosimilars, potentially reducing treatment costs by fifty per cent or more. Historical examples, such as the price reduction for the cancer drug trastuzumab, illustrate the potential for significant price changes—but this process can take time, as seen with the delayed availability of affordable biosimilars.

Moreover, the Central Drugs Standard Control Organisation is considering easing regulatory constraints to facilitate faster approvals for biosimilars. This regulatory shift is crucial to ensure that Indian cancer patients can benefit from more accessible treatment options sooner rather than later.

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