COVER STORY
The global pharmaceutical industry is on the brink of a major transformation as some of the world ' s best-selling biologic drugs approach the end of their patent exclusivity. This phenomenon, often referred to as the“ patent cliff,” presents a multi-billion-dollar opportunity for pharmaceutical companies worldwide. However, one country that stands to gain significantly from this shift is India. Known for its strong generics industry, cost-effective manufacturing, and growing expertise in biosimilars, the Indian pharmaceutical sector is uniquely positioned to capitalize on the wave of patent expirations sweeping through the biopharma landscape.
Over the next five to ten years, patents for some of the most profitable biologic drugs will expire, allowing competitors to introduce biosimilars— cheaper, equally effective versions of these complex therapies. Biologics, which are derived from living organisms, have revolutionized the treatment of chronic diseases such as cancer, diabetes, autoimmune disorders, and ophthalmologic conditions. However, they come with a hefty price tag, making them inaccessible to millions of patients, especially in low- and middle-income countries. The introduction of biosimilars will not only drive down costs but also increase accessibility, and India, with its vast pharmaceutical manufacturing capabilities, is well-positioned to lead this change.
Blockbuster Opportunity
One of the most anticipated patent expirations is that of Keytruda, Merck’ s blockbuster cancer immunotherapy drug, which is set to lose exclusivity in 2028. Generating over $ 25 billion in revenue annually, Keytruda is a critical component in cancer treatment worldwide. Its patent expiry will create a massive opening for biosimilar manufacturers, and Indian pharmaceutical companies such as Biocon, Dr. Reddy’ s Laboratories, and Lupin are already investing in the necessary research and development to enter this high-value market. Similarly, Opdivo, another leading cancer immunotherapy drug from Bristol- Myers Squibb, will face biosimilar competition by 2026-2027, offering yet another lucrative opportunity.
Beyond oncology, the ophthalmology sector is also on the cusp of transformation, with Eylea, a widely used treatment for macular degeneration, losing patent protection by 2025. With millions of elderly patients relying on Eylea for vision preservation, the introduction of biosimilars could significantly reduce treatment costs and expand access. Indian companies, leveraging their cost-competitive manufacturing, can play a crucial role in making these therapies more affordable on a global scale.
The patent expiry wave is not limited to cancer and ophthalmology drugs; blockbuster treatments for autoimmune diseases are also entering the biosimilar race. Johnson & Johnson’ s Stelara, used for psoriasis and Crohn’ s disease, has already lost exclusivity in certain markets, paving the way for biosimilars. Similarly, UCB’ s Cimzia, a treatment for rheumatoid
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BioVoiceNews | April 2025