Sat Aug 02 23:30:00 UTC 2025: Okay, here’s a news article based on the provided text and the context of The Hindu:
**The Hindu: Biosimilars Hold Promise for Affordable Healthcare in India, But Regulatory Hurdles Remain**
**New Delhi, August 3, 2025** – As India grapples with the rising costs of healthcare, biosimilars – drugs similar, but not identical, to originator biologic medications – offer a potential pathway to affordability, particularly for complex treatments like rheumatoid arthritis. However, experts argue that India’s regulatory framework needs streamlining to fully realize their potential.
“Most of the drugs that you and I take are generics and are priced very cheaply compared to the originator drug. A good example is Sovaldi, a drug used to treat hepatitis C: it originally cost $84,000 for a 12-week course in the US but that dropped to $1,000 once Indian generic firms started making it. Largely it is generic drugs that keep us in India alive and well,” writes Gayatri Saberwal, consultant at the Tata Institute for Genetics and Society.
Unlike easily replicated “small molecule” drugs like Disprin, biologics are complex molecules, produced in living systems, such as monoclonal antibodies or insulin. These biologics are significantly larger and more complex than small molecule drugs, such as Disprin, which has a molecular weight of around 180 daltons, while insulin weighs around 5,800 daltons and the monoclonal antibody remicade weighs around 150,000 daltons.
When these biologics go off patent, other firms can create biosimilars. Producing perfect copies of the original is virtually impossible, so the drugs are called “biosimilars.”
Because of the complexities involved in manufacturing these drugs, regulators in various countries, including the US, the UK, and Europe, have traditionally required extensive testing to prove the safety and effectiveness of biosimilars before approving them for use. This has included animal trials and extensive clinical trials.
“For many years, a debate has raged over how much proof is required for a manufacturer to prove that a given biosimilar will work as well as the original biologic drug,” Ms. Saberwal writes.
However, there’s growing momentum globally to simplify the approval process, leveraging advanced analytical techniques to ensure biosimilar efficacy without excessively burdensome and costly trials. The UK, for example, has already eliminated animal trials, and the US is exploring alternatives like organoid studies.
In India, the current regulatory landscape has yet to fully adopt these modern approaches, although a proposal exists to waive animal studies on a case-by-case basis. Calls are growing for India to align its practices with those of countries like the UK and the US, potentially streamlining the approval process and reducing the cost of biosimilars.
Affordable biosimilars could drastically expand access to life-saving treatments, particularly for chronic diseases, says Ms. Saberwal, by providing more treatment options to patients.
“Biosimilars need to be made less expensively while ensuring efficacy and minimal adverse effects. The larger the number of affordable biosimilars, the more options we will have for our patients,” Ms. Saberwal wrote.
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