Biologics have significantly transformed the treatment landscape, yet their high costs remain a barrier for many patients in India, particularly for drugs like trastuzumab and pembrolizumab used in cancer treatment. Biosimilars, which are highly similar versions of approved biological products, present a cost-effective, safe, and effective alternative. Nevertheless, the journey to market for biosimilars is often complicated by regulatory challenges, resulting in elevated prices.
On March 16, the European Medicines Agency (EMA) adopted a reflection paper advocating for a tailored clinical approach in the development of biosimilars, marking a significant reform on a global scale. This shift means that comparative efficacy studies (CES)—which can be costly and span several years—will no longer be a routine requirement, provided that analytical and pharmacokinetic data demonstrate sufficient biosimilarity. The U.S. Food and Drug Administration (FDA) has also indicated a similar direction, with a proposal to remove mandatory CES. Such reforms could potentially shorten biosimilar development timelines from 5-8 years to 2-4 years and save manufacturers millions per product. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had already implemented this change as early as 2021, while Health Canada has released draft guidelines on eliminating CES.
In India, the Central Drugs Standard Control Organisation (CDSCO) issued draft guidelines for similar biologics in May 2025, which introduced advanced analytical methodologies and reduced reliance on animal studies, allowing for conditional waivers of Phase III trials. Although these guidelines represent progress, they lack the clarity of the EMA and MHRA frameworks. The discretionary nature of the guidelines requires case-by-case assessments for clinical trial waivers, and while animal studies have been reduced, they are still required at the discretion of regulators—contrary to global trends favoring non-animal models.
India is home to approximately 135 approved biosimilars, positioning it among the leaders worldwide, with a burgeoning biosimilar market valued around $1.5 billion and growing at an annual rate of 20%. Major manufacturers such as Biocon, Dr. Reddy’s Laboratories, Intas, Aurobindo, and Zydus are exporting biosimilars to markets in the U.S., Europe, and other emerging economies. The government’s ₹10,000 crore Biopharma Shakti mission aims to establish India as a global biosimilar manufacturing hub. With an estimated $200 billion worth of biologics expected to lose exclusivity by 2030, the Indian industry is well-positioned to capture a significant market share.
However, the existing regulatory guidelines pose challenges, as mandatory clinical trials can incur costs in the millions and result in significant delays. While international regulators recognize the need for reform, the Indian guidelines retain substantial discretion and lack a clearly defined pathway for waiving clinical trials.
As a result of this regulatory inertia, Indian patients continue to face high costs for biosimilars. Drugs like trastuzumab have already reduced costs by 60-70%; aligning Indian guidelines with those of the EMA and MHRA could reduce prices even further. Some biosimilars have been included in Central and State government schemes offering health insurance coverage, and more comprehensive guidelines could enhance accessibility.
India became the first country to approve a biosimilar in 2000, ahead of both Europe and the U.S., and it possesses the requisite manufacturing capability, scientific expertise, and market demand. The Biopharma Shakti mission has set a promising direction, and the CDSCO’s guidelines must now reflect clear scientific standards instead of relying on subjective discretion.
Chetali Rao, Senior Researcher at the Third World Network, authored this piece, where expressed views are personal.
Published on May 18, 2026.
