One of the world’s best-selling immunotherapies – pembrolizumab – that has emerged over the last several years as a cornerstone of many hard-to-treat cancers – remains out of reach for most cancer patients in India.

The recent approval of pembrolizumab for a specific subset of ovarian cancers by the US Food and Drug Administration (FDA) has once again spotlighted the drug’s transformative potential in oncology.

Marketed as Keytruda, the immunotherapy has steadily expanded its footprint across multiple cancer types over the past decade, offering hope where conventional treatments often fall short, pointed out an oncologist at the country's premier cancer institute, Mumbai-based Tata Memorial Centre (TMC).

Yet, even as global indications grow and survival benefits become more evident, a stark reality persists for India: for the vast majority of patients, meaningful access to this life-extending therapy may still be at least two years away.

The reason lies not in science, but in economics – specifically, the drug’s patent protection, which remains in force until June 2028.

“It's a pity that many cancer patients cannot accept any reprieve as the drug’s prices are likely to be very high for the next two years,” said K M Gopakumar, legal researcher with international non-profit Third World Network.

India reports over 15 lakh new cancer cases every year and more than 9 lakh deaths annually due to various malignancies. Also, estimates suggest that less than 3 percent of cancer patients in the country can access new class immunotherapy drugs such as Keytruda, that improve overall survival and quality of life for cancer patients.

A DECADE OF DOMINANCE

Since its first approval in 2014, pembrolizumab has emerged as one of the most significant breakthroughs in cancer care. It has become the backbone of treatment across at least 22 malignancies, including lung, bladder, skin, kidney, and endometrial cancers.

Its inclusion in the World Health Organisation’s (WHO) Model List of Essential Medicines in September 2025 further cemented its importance, particularly as a first-line therapy for metastatic cervical cancer, colorectal cancer, and non-small cell lung cancer.

The drug works by harnessing the body’s immune system – a fundamentally different approach compared to chemotherapy or radiation.

By targeting the PD-1 protein on T cells, pembrolizumab effectively removes the “brakes” that prevent immune cells from attacking cancer. This allows the body to recognize and destroy malignant cells more efficiently, often resulting in longer survival and, in some cases, durable remission.

Globally, this has translated into unprecedented demand. The drug is now the world’s top-selling cancer therapy, generating tens of billions of dollars annually. For patients in high-income countries, it has redefined treatment expectations.

For many in India, however, it remains aspirational.

The most immediate barrier to access is cost. A full course of treatment with pembrolizumab, often spanning 18 months, can cost as much as Rs 50 lakh. For some patients, the yearly cost of treatment can be as high as Rs 1.2 crore annually.

This is far beyond the reach of most Indian households, where healthcare expenditure is still largely out-of-pocket.

Also, as the drug is still not part of India’s National List of Essential Medicines, even beneficiaries under public-funded schemes like Ayushman Bharat-Pradhan Mantri Jan Aarogya Yojana (AB-PMJAY), pointed out Chetali Rao, who like Gopakumar, too, works on facilitating drug access to the needy.

Additionally, private insurance policies frequently cap payouts or exclude such treatments altogether.

As a result, oncologists are often forced into difficult conversations with patients – balancing clinical benefit against financial devastation. For many families, pursuing treatment with pembrolizumab means depleting savings, selling assets, or taking on unsustainable debt.

An important study by TMC researchers that came out just last month showed that a standard six-month course of Keytruda costs 7,994 percent of the average monthly income in India.

The study had estimated that the cost of the drug for an average patient is about Rs 10.1 lakh per month, adding up to over Rs 1.2 crore annually.

HOPE BEYOND 2028

While high prices are a challenge globally, in India they are exacerbated by patent protections that prevent the entry of cheaper alternatives. Keytruda’s patent, held by its manufacturer US based Merck \& Co, remains valid until June 2028 in India.

Until then, generic or biosimilar versions cannot be freely produced and marketed at scale within the country.

This effectively locks in high prices, as competition – the primary driver of affordability in pharmaceuticals – is absent. Indian drugmakers, known for producing low-cost generics, are unable to step in meaningfully until the patent expires or is otherwise bypassed through legal or policy interventions.

Compulsory licencing, a mechanism that allows governments to authorize generic production in public health emergencies, remains a theoretical option. However, its use in India has been rare and politically sensitive, particularly for high-profile global drugs.

The expiration of the patent in 2028 is widely seen as a turning point. Once biosimilar versions enter the market, prices are expected to drop significantly – potentially by as much as 50 percent or more, based on historical trends with other biologics – more complex medicines as compared to small molecules.

But Gopakumar pointed out that despite Roche’s cancer drug – used for treating malignancies of breast and stomach – trastuzumab (Herceptin)'s patent expiry in 2012 – which cost Rs 1.2 lakh per vial – the biosimilar version launched by Biocon still cost Rs 55,000 per vial.

It was only in 2024 with the launch of Glenmark’s biosimilar version of the drug that its price really came down – around Rs 15,000 per vial.

According to Rao, that’s because biosimilar drugs – unlike generics of small molecule drugs – are still required to carry out animal and late-stage human studies.

“India’s Central Drugs Standard Control Organisation (CDSCO) – on the life US FDA and European Union drug regulator has proposed to ease these norms – in order to pave way for faster approval of these medicines. But that needs to be fast-tracked so that cancer patients can benefit sooner than later,” she said.

- Ends

Published On:

Apr 13, 2026 17:39 IST