COVER STORY
arthritis and Crohn’ s disease, is set to face biosimilar competition in the coming years. These therapies represent a massive market, and Indian firms that can successfully navigate the regulatory hurdles stand to gain significantly.
What’ s Working In India’ s Favor?
One of India’ s biggest advantages in this space is cost efficiency. Biologic drug manufacturing is complex and expensive, often requiring investments of up to $ 200 million to bring a biosimilar to market. Indian pharmaceutical companies have consistently demonstrated the ability to manufacture high-quality medicines at lower costs than their Western counterparts. This cost advantage extends to biosimilars, which are complex and expensive to develop. By leveraging economies of scale and efficient manufacturing practices, Indian firms can provide affordable alternatives to costly biologics, driving wider market adoption.
The demand for biosimilars is rising. Governments and insurers worldwide are encouraging biosimilar adoption to reduce healthcare expenditure. With increasing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders, biosimilars can offer costeffective treatment solutions. Agencies like the U. S. FDA and the European Medicines Agency( EMA) have established clear regulatory pathways for biosimilars, facilitating their approval and market entry.
India, with its regulatory expertise and track record in generics, is well-positioned to meet this growing demand. While India has already established a foothold in emerging markets, the expiry of biologic patents opens doors for deeper penetration into regulated markets such as the U. S., EU, and Japan. Companies like Dr. Reddy’ s, Biocon, and Lupin are actively investing in R & D, regulatory approvals, and partnerships to expand their biosimilar presence in these markets.
Proven‘ Trustworthy’ Trackrecord
India has established itself as a global leader in the production of biosimilars. Companies such as Biocon, Dr. Reddy’ s, Cipla, Zydus Cadila, and Intas Pharmaceuticals have successfully launched biosimilars in global markets, including the U. S. and Europe. The expertise in biologics manufacturing, regulatory compliance, and cost-effective production gives Indian firms a competitive edge. Biocon, for instance, has already commercialized biosimilars of insulin, trastuzumab, and pegfilgrastim in key markets, including the U. S. and EU, in collaboration with Mylan( now Viatris).
By leveraging this experience, Indian firms can accelerate their entry into the biosimilars market for high-value biologics whose patents are expiring. However, succeeding in this competitive space requires more than just manufacturing capabilities— it demands advanced research and development, robust clinical trials, and stringent regulatory compliance.
To maximize the opportunity presented by the patent cliff, Indian pharmaceutical
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BioVoiceNews | April 2025