India's draft guidelines on biosimilar drugs can make treatments more accessible, affordable
Biosimilars present a vital opportunity to increase patients' access to biological therapies and reduce the burden on healthcare systems. Although biosimilar drugs are hailed as a pathway for providing better access to expensive and unaffordable drugs, their production is fraught with hurdles, including high cost and regulatory barriers. Unlike conventional generic medicines, bringing a biosimilar drug to the market requires substantial scientific expertise, advanced technological capabilities, and a robust regulatory apparatus. These challenges have hindered the pace of biosimilar development and limited their adoption and uptake globally.
Biologic drugs have become the cornerstone of medical treatment, offering therapies for a number of diseases. Unlike traditional medicines that offer a one-size-fits-all approach, many biologics have a very targeted approach to disease management and treatment. These transformative therapies have altered the treatment landscape for multiple diseases, including cancer and autoimmune disorders. Biosimilars are biological products that are highly similar to approved reference or innovator drugs, with no clinically meaningful differences in terms of safety, purity, and potency.
Limitations
India has emerged as the global frontrunner in the commercialisation and approval of biosimilars. The country approved its first biosimilar in 2000, well ahead of similar regulatory action in Western markets — the European Union approved the first biosimilar in 2006, while the US approved nearly 10 years later in 2015. The formulation of the Central Drugs Standard Control Organisation (CDSCO) biosimilar evaluation process in 2012 and revision of the guidelines in 2016 provided the much needed regulatory rigour and accelerated the pace of approvals. With 135 approved products as of January 2025, spanning across various therapeutic areas, India has surpassed both the US and Europe.
Though India has built a robust domestic biosimilar market, its international presence and the ability to lower prices as compared to small molecule generics remains limited. One of the major reasons has been the inability to align with the scientific and technological advancement happening globally. The changes in the stances of global regulatory bodies signal a potential evolution in the biosimilar landscape and present an opportunity for Indian regulators to align their regulations with those of the UK, EU, and Canada. These global regulatory changes, coupled with the impending biosimilar void, provide a golden opportunity for Indian biosimilar manufacturers to remove the high investment barrier and expand their footprint globally.
Reflecting a shift in the biosimilar landscape and global regulatory alignments, the CDSCO released its draft revised Guidelines on Similar Biologics in May 2025. These updated guidelines seek to align India's regulatory approach with established frameworks, specifically the WHO Technical Report Series No. 1043, European Medicines Agency (EMA), and the US Food and Drug Administration (FDA) frameworks. Some of the key changes in the draft guidelines include an increased focus on strengthening the analytical and structural characterisation and in-vitro comparability of biosimilars. Additionally, the guidelines also emphasise on following the principle of 3Rs (Replace, Reduce, Refine) for animal studies, allowing conditional waivers for clinical efficacy studies, and advancing interchangeability practices.
Though the focus on 3Rs reflect India's commitment to ethical science and global standards that prioritise animal welfare, it still allows for animal studies in some cases and also leaves the discretion to the licensing authorities. Many of the international developed regulatory bodies like the UK's Medicines and Healthcare products Regulatory Agency, EMA, Health Canada, and USFDA have increasingly shifted away from animal testing and moved to non-animal models. In a ground breaking development, the USFDA has even decided to phase out animal testing for development of products like monoclonal antibodies. But the CDSCO's draft guidelines allowing conditional waivers in place of a complete waiver for animal testing can lead to increased ambiguity, which will increase cost for biosimilar manufacturers and delay access to affordable biosimilars.
Also read: India's top students wanted to be doctors. Not anymore
A historic opportunity
In terms of waiver for clinical trials, there is an increasing shift in the global paradigm in countries like the UK, EU, and Canada where clinical efficacy studies are regarded as an exception rather than a rule for regulatory approval of biosimilars. These changes do not reflect a radical break, but show decades of scientific and regulatory experience with product approvals and data evidence.
These jurisdictions have embraced more nuanced approaches and established clear science-driven criteria for when clinical trials will be truly necessary. Health Canada draft guidelines have moved further by requiring the clinical trial sponsor (biosimilar manufacturer) to provide rationale for conducting clinical trials. In contrast, Indian guidelines grant considerable discretion to the licensing authority, without delineating scenarios where such trials will be required. This lack of clarity not only risks regulatory arbitrariness, but will also inflate development costs.
India stands at a critical junction of biosimilar innovation. Amidst rapid advancements in its scientific prowess, policy shifts, and an evolving regulatory landscape, it is well-positioned to spearhead advancements in producing affordable biosimilars. The 2025 Draft Guidelines on Similar Biologics offer a historic opportunity to advance India's healthcare system. By removing persisting ambiguities in animal studies, clarifying conditions for clinical trials, and prioritising affordability, it will not only provide the much needed impetus to India's biosimilar industry but can also make biosimilars more accessible and reinforce India's leadership in affordable medicine.
Chetali Rao is a Senior Scientific Researcher and Legal Advisor at Third World Network. Views are personal.
(Edited by Aamaan Alam Khan)
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Some blame an anti-vaccine sentiment growing in the U.S. and other countries that have largely funded eradication efforts and say it's reaching even remote areas of Afghanistan and Pakistan. In suburban southwest Pakistan, Saleem Khan, 58, said two grandchildren under 5 were vaccinated over his family's objections. "It results in disability," said Khan, without citing evidence for his belief. "They are vaccinated because officials reported our refusal to authorities and the police." Svea Closser, professor of international health at Johns Hopkins University, said Pakistan and Afghanistan were less resistant to immunization decades ago. Now, people are angry about the focus on polio and lack of help for diseases like measles or tuberculosis, she said, spurring conspiracy theories. "Polio eradication has created a monster," Closser said. It doesn't help, she added, that in this region, public trust in vaccine campaigns was undermined when the CIA organized a fake hepatitis drive in 2011 in an attempt to get DNA and confirm the presence of Osama bin Laden or his family. Workers see that continued mistrust every day. In a mountainous region of southeastern Afghanistan where most people survive by growing wheat and raising cows and chickens, a mother of five said she'd prefer that her children be vaccinated against polio, but her husband and other male relatives have instructed their families to reject it. They believe the false rumors that it will compromise their children's fertility. "If I allow it," the woman said, declining to be named over fears of family retribution, "I will be beaten and thrown out." (Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
