Mumbai: Sun Pharma’s $11.75 billion acquisition of US-based Organon & Co. has pushed the Indian drugmaker into the global biosimilars market and and positions it among the top 10 players in the segment, as it bets on a wave of biologics patent expiries over the next decade.
“There are $320 billion worth of biologics losing patents by 2035. If you convert this to the biosimilars market, that can be a market opportunity worth $70 billion,” managing director Kirti Ganorkar told reporters in a press conference on Monday, noting that Organon’s biosimilar business has grown at a compound annual growth rate of 13% over the last five years.
Sun Pharma plans to leverage Organon’s commercialization platform for in-licensing and future launches, it highlighted in its investor presentation.
Relatively small
However, biosimilars remain a relatively small and less profitable part of Organon’s business. In 2025, the portfolio generated $691 million, or about 11% of total revenue, with $310 million, or roughly 45%, coming from outside the US, according to Organon’s FY25 annual report.
The portfolio spans immunology and oncology therapies for which Organon holds global commercialization rights, with geographic exceptions across its eight products.
“Such exceptions are governed by agreements that we entered into with Samsung Bioepis Co., Ltd (“Samsung Bioepis”) and Shanghai Henlius Biotech, Inc. (“Henlius”),” Organon noted in its annual report. These arrangements exclude certain key markets, including the European Union (EU), China and South Korea, for some products.
“Organon’s biosimilars business is not fully integrated, lowering profitability,” said Vishal Manchanda, pharma analyst at Systematix Group. The second challenge lies in the US Food and Drug Administration’s proposed new biosimilar guidelines, which proposes to make all biosimilar products interchangeable, easing entry of new products in the market.
If these guidelines go into effect as it is, “one may not need commercial infrastructure, and Organon’s manufacturing partners could market biosimilars themselves,” said Manchanda.
The biosimilars bet
Sun Pharma’s push into biosimilars comes after years of staying largely on the sidelines due to regulatory uncertainty. Executive chairman Dilip Shanghvi told reporters on Monday that developing biosimilars in-house would have required six to eight years.
“The reason why we were not investing in biosimilars is there was no clarity about substitution as well as interchangeability,” said Shanghvi. “There is now greater regulatory clarity on both of these issues. At the same point of time, the potential cost of registering a product is likely to come down because many of the products may qualify to potentially avoid clinical studies,” he added.
The company is now looking beyond Organon’s existing portfolio, aiming to use its commercial network to expand into new biotech products. “We will continue to look out for opportunities to invest,” said Shanghvi.
Using Organon’s commercial footprint for licensing deals will be one of the biggest long-term levers of the acquisition, said Manchanda. In the near term, however, investors are focused on over $350 million in expected synergies, a rapidly deleveraging balance sheet, and the expanded global commercial access Sun Pharma gains through the deal.
