Zydus Lifesciences: Indian pharma company Zydus Lifesciences has taken a major step towards cancer treatment. The company has developed the world’s first publicly disclosed cheaper alternative (biosimilar) to the world’s best-selling cancer drug Keytruda (pembrolizumab). America’s leading health agency US FDA has accepted the company’s application for review of this new drug of Zydus. If the drug receives final approval from the FDA, Zydus will become one of the first few companies to enter the US market. Merck (MSD in India), the maker of the drug Keytruda, earns more than $30 billion a year from this drug. This new initiative by Zydus is only expected to make cancer treatment cheaper.

Why is this new drug special for cancer patients?

Keytruda is a very effective drug that stops the growth of cancer cells. This drug works by blocking the PD-1 receptor. Currently, this drug is used in the treatment of 19 different types of cancer. This includes serious cases like skin, lung, breast and stomach cancer. Renowned oncologist Dr. Sunil Chopra of Jaslok Hospital in Mumbai said that the scope of Keytruda is very wide. It has proven to be very effective in increasing the life expectancy of patients. He clarified that this cheaper alternative developed by Zydus will drastically reduce the cost of the drug.

This will benefit the patients who cannot afford these expensive medicines due to lack of money. Zydus Managing Director Sharvil P Patel also said that this is a very important step towards providing affordable medicines to patients in the US and Canada. Patel also clarified that the company’s aim is not just to sell drugs, but to make new generation cancer treatments easier for patients. Zydus has been investing heavily in the oncology space for a long time.

How will the company benefit in the market?

Zydus developed this new drug (FYB206) together with Formicon AG, an independent company based in Munich. An exclusive agreement was signed between the two companies in December 2025. Under this agreement, Zydus has exclusive rights to sell this drug in the US and Canadian markets. Formicon will oversee the drug’s development, regulatory filings and supply. After accepting the application, Formicon will now also receive a fixed payment from Zydus.

The company submitted its application for approval in the third quarter of 2026. Now the FDA will fully evaluate this drug. It is expected that the agency will give its final decision by the third quarter of 2027. In addition, the company has also filed its application with Health Canada. Looking at data from DrugPatentWatch, the approval rate for biosimilar drugs accepted for review by the FDA has historically been over 90 percent.

Competition between firms before patents expire

Keytruda is the world’s largest biologic drug by sales. Its total sales will reach $31.7 billion in the year 2025. The drug has earned $16.40 billion in the first six months of 2026. Merck’s original patent is set to expire in 2028. However, analysts believe that Merck has also filed several new patents that could extend its monopoly until 2031. Merck is fully prepared to maintain its dominance, so the road for Zydus will not be so easy. Systematics Group analyst Vishal Manchanda says Merck is fully prepared to give tough competition to other companies.

Meanwhile, many other companies have also jumped into the race to take advantage of this huge market opportunity. In September, Cipla’s American subsidiary Invegen signed a deal with Chinese company Kulu. Companies like Biocon and Sandoz are also leading the race to bring their own alternatives. Amidst all this, one good thing for Zydus is that the company has completed the development of the drug without a lengthy phase III trial. Stefan Glombitza, CEO of Formicon AG, said that this route was chosen as early as 2025 with FDA approval. This helped to develop medicine faster.