On Verge of Expiry, the Race to Replicate Keytruda Begins

World’s best-selling drug Keytruda, hits on to the verge of expiry, which drives manufacturers rushing to replicate the generic version of the drug.

Keytruda is known to be the best cure for cancer, which is scientifically known as pembrolizumab.

In 2025 alone, Keytruda brought sale of USD 30 billion. That places this special miracle drug ahead of the other pioneering drugs like Ozempic. The Company behind this innovative drug is Merck & Co.

Cancer is one of the most impossible diseases to fight. It is not that the difference between patients and their body, rather the tumor itself has a nature of its own.

That is different cancer cells, acts on each body differently. Even though a medicine is developed to kill the tumor. There is always a good chance of 1 percent of sub clones with a different a genetics that could survive.

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How Cancer cells works

Pharmaceutical industry’s greatest hurdle is to fight the cancer. Ideally the human body fights the cancer through immune surveillance.

Where the white blood cells like T-cells would identity, target and destroy the cancer cells. Thereby these dying cells would release abnormal proteins called neo- antigens.

These neo-antigens manage to hide in the surface level. This in return shuts down the T-cells in fighting an infection.

Keytruda plays Smart

Until the arrival of Keytruda, there was primarily two ways of fighting the cancer:

• The chemotherapy where, all the rapidly divding cells are poisoned.
• Secondly using drugs like imatinib, to hunt on the specific proteins that cancer dwells on and block it.

In both of the methods the cancer cells where directly attacked, like flushing out all of it from the body. As in chemotherapy, understanding that the cancer cell rapidly divides, similarly the gut lining, hair follicles, bone marrow also divides. Therefore the chemo would attack them all at once.

However Keytruda acts different, it doesn’t attack the cancer cells, and rather it cuts off the ability of cancer to hide from body’s immune system.

Future of Keytruda

The company behind the famous drug Merck & Co has announced new plans for after 2028. Merck’s is expected to hit a top patent. As this is an opportunity worth of billions of dollar for many pharmaceutical manufacturers around globe.

This can be beneficial for the cancer patients across the world. A single 100mg imported vial costs around 2.36 lakhs a rupee, which is annually about 50 lakhs rupees.

Even though, replicating a drug like Keytruda wouldn’t be easy, but there is a clear hope for good chances.