Revolutionising healthcare: How biosimilar reforms can transform India's drug access
26-year-old Seba Salam has been bedridden since 2017 due to Spinal Muscular Atrophy (SMA) Type 2, a genetic and progressive disorder. Yet, the condition has not stopped her from becoming an artist, published author, and blogger. More importantly, Seba has emerged as one of the strongest voices advocating for access to life-saving drugs, especially for rare and genetic diseases, across various platforms—including legal forums.
She has been outspoken about the role of patent monopolies in keeping these essential medicines unaffordable, often declaring that “life-saving drugs should not be treated as profit-generating commodities.”
Recently, while interacting with The Week, Salam noted the example of Onasemnogene abeparvovec (Zolgensma), a one-time intravenous gene therapy, that can save a lot of children affected with SMA, costed Rs 16 crore in India.
In April 2023, representatives from various civil society groups, community organisations, health bodies, and patient advocacy groups wrote an important letter to the Department of Health and Family Welfare and the Department of Biotechnology.
The letter highlighted the exorbitant cost of Zolgensma and seven other life-saving drugs. It urged the government to reform its policies on biosimilars—biological medicines that closely resemble an approved product in quality, safety, and efficacy, but are produced by a different company. The signatories emphasised that such policy changes could dramatically improve the lives of many, including many individuals like Seba. The letter urged the government to take immediate steps to revise the pre-existing Biosimilar Guideline, last revised in 2016, and facilitate access to quality biosimilars at an affordable price. It also noted that the current Biosimilar Guidelines require mandatory animal studies and comparative safety and efficacy trials for marketing approval. These requirements were identified as major barriers to biosimilar approval, as they are both resource-intensive and time-consuming. As a result, fewer manufacturers enter the market, limiting competition and keeping the prices of originator medicines high.
Incidentally, this May, the Central Drugs Standard Control Organization (CDSCO) released new Draft Guidelines on biosimilars—a move seen as a significant step toward making affordable, life-saving treatments accessible to millions of Indians suffering from serious illnesses.
However, civil society groups are urging for further relaxation of these guidelines in line with global standards, to remove unnecessary barriers and prioritize affordability without compromising safety and efficacy.
Notably, the draft includes provisions to reduce animal testing and incorporates the 3Rs principle—Replacement, Reduction, and Refinement—which promotes ethical animal research by encouraging alternatives and minimizing animal use.
Yet, K.M. Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatment, points out that the draft still permits animal studies in certain cases and leaves much to the discretion of licensing authorities. He argues that advanced technologies like in-vitro testing, organ-on-chip models, and computer simulations can reliably demonstrate a biosimilar’s safety and similarity to the original drug. Gopakumar, who recently submitted a petition to the CDSCO urging a revision of the draft, notes that leading regulatory bodies such as the UK MHRA, EMA, Health Canada, and USFDA have largely moved away from animal testing. Eliminating such 'unnecessary' tests in India, he contends, could lower production costs and accelerate biosimilar development.
The new draft guidelines include a provision that makes clinical trials optional when a biosimilar is proven to be similar through laboratory tests. However, civil society organizations point out that the guidelines do not explicitly mention the specific situations in which a biosimilar developer would be required to conduct comparative clinical trials—something clearly outlined in the guidelines issued by agencies like the UK MHRA.
There is optimism that the new biosimilar guidelines present a historic opportunity to advance India’s healthcare system. Activists like Gopakumar note that by eliminating animal studies, clarifying clinical trial waivers, and prioritizing affordability, India can make biosimilars more accessible, reduce ethical concerns, and strengthen its position as a global leader in affordable medicine.
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