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The Swadeshi Jagran Manch (SJM), a public interest platform committed to self-sufficiency and equitable access to medical treatments, has requested the central drug regulator to eliminate animal studies entirely when comprehensive laboratory tests demonstrate high similarity between a biosimilar and its reference product and ensure that biosimilars are priced affordably for all patients.
In a letter to the head of the Central Drugs Standard Control Organisation (CDSCO), the SJM has demanded enhancement to the draft guidelines on Similar Biologics, released by the drug regulator recently for finalisation.
"Biosimilars hold immense promise for transforming healthcare in India by offering cost-effective alternatives to expensive biologic medicines. In a country where many patients face significant financial barriers to accessing basic healthcare, these guidelines are a beacon of hope. However, to maximize their impact and ensure that biosimilars reach all who need them, we strongly urge the CDSCO to consider the following enhancements to the Draft Guidelines," it said.
The Manch applauded the draft guidelines for embracing the 3Rs principle (Replacement, Reduction, Refinement), reflecting India’s commitment to ethical scientific practices and alignment with global standards for animal welfare. Modern technologies, including in-vitro assays, organ-on-chip models, and computational simulations, provide robust, accurate, and humane alternatives to confirm the safety and biosimilarity of these drugs. These methods are often faster and more precise than animal studies, reducing both ethical concerns and development costs.
However, it added, the Draft Guidelines the waiving of animal studies is at the discretion of the CDSCO. The Draft Guideline reads: “On the basis of the totality of quality and nonclinical in vitro data available and the extent to which there is residual uncertainty about the similarity of a similar biologic and its RBP, it is at the discretion of Licensing Authority to waive or not to waive a requirement for additional nonclinical in vivo animal studies”. As a result, the waiver is at the discretion of the CDSCO.
"This provision not only risks increasing biosimilar development cost but also goes against the practices of the leading regulatory authorities," said Dr. Ashwani Mahajan, National Co-Convenor, SJM. Prominent regulatory authorities like the UK MHRA, European Medicine Agency (EMA,) Health Canada, and USFDA have either eliminated or phased out mandatory animal testing for biosimilars.
"Waiving animal studies entirely when comprehensive laboratory tests demonstrate high similarity between a biosimilar and its reference product," demanded Mahajan.
The draft guidelines’ provision to waive certain clinical trials when bio similarity is established through analytical and functional studies is a forward-thinking measure. This approach can significantly reduce development costs and expedite market entry, which is critical for patients awaiting affordable treatments. However, the lack of explicit criteria for when waivers are permitted introduces ambiguity, potentially leading to inconsistent application and delays as well as room for corrupt practices.
In order to enhance clarity and efficiency, it urged the CDSCO to define specific, evidence-based conditions when clinical efficacy trials will be needed as reflected in the case of EMA Reflection Paper, and ensure consistent application of these criteria for waivers across all biosimilar applications. A transparent and standardized waiver process will enable manufacturers to prioritize the production of high-quality, cost-effective biosimilars, ultimately benefiting patients across India, it averred.
It should also prioritize affordability and accessibility of these medicines. Biosimilars have the potential to extend this legacy, but only if regulatory processes minimize unnecessary costs. Requirements for animal studies or unclear clinical trial mandates can drive up production expenses, making biosimilars unaffordable for many Indians, particularly those in rural and low-income communities.
To ensure biosimilars remain accessible, it requested the CDSCO to streamline the approval process to eliminate cost-driving requirements, ensuring biosimilars are priced affordably for all patients.
There is also need to safeguard India’s generic and biosimilar industry from international pressures to adopt costly regulations that favor multinational pharmaceutical companies. It should support local manufacturers to enhance their regulatory compliance capacity and encouraging domestic production of biosimilars to foster competition and innovation. These measures will reinforce India’s leadership in global healthcare, ensuring that quality biosimilars are accessible to patients in India and other developing nations, while supporting economic growth through a robust biosimilar industry, added Mahajan.
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