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The Print
a day ago
- Health
- The Print
India's draft guidelines on biosimilar drugs can make treatments more accessible, affordable
In India, healthcare affordability is a critical issue, and biosimilars can play a pivotal role in making advanced therapies accessible to a broader population. India's dynamic pharmaceutical ecosystem positions the country to become a global leader in biosimilar production. The government has initiated multiple policy reforms and introduced capacity building initiatives in the form of National Biopharma Mission (NBM) and the Production Linked Incentive (PLI) scheme to boost domestic biosimilar production. But significant obstacles remain concerning regulatory policies and market accessibility. Hence, promoting safe, efficacious, and affordable biosimilars requires a comprehensive strategy — one that not only encourages innovation through research and development, but also streamlines the regulatory processes and ensures rigorous quality standards. 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)
Hindustan Times
5 days ago
- Health
- Hindustan Times
How India's biopharma industry is tackling the world's next health challenges
India has established itself as the pharmacy of the world. Supplying nearly 20% of the global generics market and 60% of the vaccine market, the country has established a strong foundation for affordable, large-scale pharmaceutical production. However, as global health challenges evolve, from infectious outbreaks to chronic lifestyle diseases, India's approach must also adapt. With non-communicable diseases like cardiovascular issues, diabetes, and others now making up over 70% of global deaths, the focus shifts from just volume to precision. If India wishes to maintain its global leadership and meet its ambitious goal of reaching a $300 billion biopharmaceutical industry by 2030, it must embrace next-generation therapies, such as gene therapies, antibody-drug conjugates (ADCs), and personalised medicine. Pharma(Pixabay/Representative) Fortunately, India, with its scientific talent, robust infrastructure, and exceptional population diversity, might be the launchpad the world needs. A significant milestone in India's biotech journey came in October 2023, when the CDSCO approved the country's first homegrown CAR-T cell therapy, NexCAR19. Developed entirely in India, this therapy for leukaemia and lymphoma showed response rates comparable to global CAR-T treatments. What sets it apart is the fact that it's being made available at a fraction of the typical price, making it a landmark in affordable, advanced immuno-oncology and India's first indigenously developed gene therapy. India is also making strides in antibody-drug conjugates (ADCs), that is, targeted cancer drugs that combine antibodies with potent toxins. Human trials for the first India-developed ADC candidate began in 2024. Meanwhile, the private sector is investing heavily in ADC manufacturing infrastructure. This comes at the right time: the global ADC market is expected to hit $23 billion by 2030, and India is positioning itself as a competitive, low-cost developer in this high-growth space. When it comes to precision medicine, India offers a uniquely rich landscape. With 1.4 billion people spanning diverse genetic, ethnic, and environmental backgrounds, it provides an ideal setting for testing and refining personalised therapies. The country also faces a dual burden of disease: persistent infectious threats like tuberculosis, accounting for 26–27% of global cases, alongside a rising tide of non-communicable diseases like diabetes and cardiovascular diseases. This diversity creates a robust, varied patient pool for clinical trials and real-world evidence studies. It's exactly what precision medicine needs: treatments that work not just in ideal conditions but in complex, real-world settings. Geographic and climatic variation, from the Himalayas to the coastal tropics, further adds to India's advantage. Significant strides in these arenas have been made possible due to active policy impetus. A cornerstone of India's biopharma push is the National Biopharma Mission, backed by ~$250 million from Indian and World Bank support. It enabled the country's first CAR-T trials and established a GMP-grade viral vector facility, fostering industry-academia collaboration and seeding a thriving biotech startup ecosystem. The government's ₹15,000 crore PLI scheme for the pharmaceutical industry is driving domestic production of complex biologics, vaccines, and high-value drugs. Covering 68 biopharma products and 157 priority drugs, it has approved 55 projects and already catalyzed over ₹30,600 crore in investment and ₹1.83 lakh crore in output by September 2024. The initiative aims to reduce India's import dependence and position the country as a global hub for advanced pharmaceutical manufacturing. The Ayushman Bharat Digital Mission is building a rich, anonymised health data backbone, enabling real-world evidence and post-market surveillance, and laying the foundation for precision medicine at a population scale. As DBT notes, India's genomic diversity is as varied as its culture or cuisine. Leveraging this scientifically will help address diseases that disproportionately affect Indian and developing-country populations. To this end, India is already scaling its genomic science to the population level. The Genome India Project has already sequenced 10,000 genomes from 83 ethno-linguistic groups and, as of January 2025, made this dataset publicly available. The government now targets 10 million genomes, supported by allied programs like CSIR's IndiGen and ICMR's National Genomics Core, which together are building reference variants for Indian populations. This genomic trove, paired with extensive patient registries, positions the country as a future hub for precision medicine and pharmacogenomics tailored to its uniquely diverse population. Despite strong momentum, India's biopharma industry must address a few critical roadblocks to realise its potential in advanced therapeutics fully. First, the regulatory framework needs to be strengthened. While CDSCO has deep experience with generics and vaccines, clear pathways for novel biologics, gene therapies, and precision medicine are still evolving. To this end, India must develop science-led, globally aligned regulatory guidelines with dedicated review pathways for advanced therapies, similar to the US FDA's breakthrough designation. Second, funding for innovation remains a bottleneck. Between 2013 and 2022, Indian biotech firms raised just $5 billion in venture capital, compared to $57 billion by U.S. biotech companies in 2023 alone. The government has tried to fill this gap through BIRAC grants and incubators and has recently proposed a Research-Linked Incentive (RLI) scheme to reward private R&D investments. Third, there is a talent shortage in high-end biopharma R&D and biomanufacturing. India's biopharma talent resilience score dropped from 6.3 in 2021 to 5.6 in 2023, and nearly half of pharma executives report difficulty hiring for critical roles. There is an immediate need to invest in specialised skill development programs for biologics, data science, and regulatory science to bridge this gap. Dr Tedros Adhanom Ghebreyesus, Director-General of the WHO, once said: 'Health is a human right. No one should get sick or die just because they are poor or because they cannot access the care they need.' India has the potential to turn that principle into practice by making the next generation of therapies not only practical but also accessible and affordable. If it succeeds, India won't just lead the biopharma race; it will redefine who gets to benefit from the future of medicine. This article is authored by Ankush Kapoor, co-founder and CEO, PharmNXT Biotech.
