Moderna and Merck's successful Phase 3 trial for a personalized mRNA cancer therapy has renewed investor interest in the oncology market. With Merck’s blockbuster drug Keytruda central to this combination, Indian pharmaceutical firms like Zydus Lifesciences, Biocon, and Dr. Reddy’s—all developing biosimilar versions of the drug—are in focus. Investors are assessing the long-term potential as these companies prepare for the post-patent market.
Moderna and Merck have reported positive interim results from their Phase 3 clinical trial, known as INTerpath-001, which tested a personalized mRNA cancer therapy (V940) in combination with Merck’s blockbuster immunotherapy drug, Keytruda. The study, conducted on patients with resected stage IIB-IV melanoma, showed significant improvement in recurrence-free survival compared to using Keytruda alone. This success validates the potential of combining mRNA technology with established cancer treatments, sparking global investor attention.
For the Indian pharmaceutical sector, this development is indirectly significant because of the drug Keytruda (pembrolizumab). Keytruda is one of the world's highest-selling cancer drugs, with reported global sales of approximately $29.5 billion in 2024. As patents on the drug begin to expire in major markets starting around 2027-2028, several Indian pharmaceutical companies are racing to develop and launch biosimilars. A biosimilar is a highly similar, approved version of a complex biological drug that acts as a lower-cost alternative once the original drug's patent exclusivity ends.
Several major Indian firms have publicly detailed their work in this space. Zydus Lifesciences is working on its biosimilar candidate, FYB206, through a partnership with Formycon, and has reported positive early study results. Biocon Biologics has indicated plans to include Keytruda biosimilars in its expanded oncology portfolio to tap into the high-demand cancer treatment market. Additionally, Dr. Reddy’s Laboratories has a global collaboration with Alvotech to develop and commercialize a version of the drug.
Investors should note that the clinical success of the Moderna-Merck combination therapy does not translate into immediate revenue for these Indian companies. The market opportunity for biosimilars is heavily dependent on several factors beyond just the drug’s popularity. First, these companies must successfully navigate the complex USFDA approval process, which requires proving that their biosimilars are as safe and effective as the original product.
Second, the legal landscape is a major hurdle. The pharmaceutical industry often sees intense patent litigation when biosimilar makers attempt to enter the market. Even if a biosimilar is technically ready, the original manufacturer often defends its intellectual property, which can delay commercial launch for years. Furthermore, the success of Moderna's combination therapy is currently specific to melanoma. Whether this combination proves effective in other common cancers, such as lung or bladder cancer, will determine the long-term sustainability of demand for the underlying Keytruda drug.
The next important developments for investors to track include updates on patent litigation regarding Keytruda, filings by these Indian companies with the USFDA for approval, and further clinical data confirming the efficacy of the Moderna-Merck combination therapy in broader patient groups.