NEED FOR SPEED. A tailored clinical approach can hasten biosimilar development and lower costs | Photo Credit: HRAUN

Biologics have transformed the treatment landscape, but are steeply priced. Drugs such as trastuzumab and pembrolizumab, which are used in treating cancer, remain unaffordable to many Indian patients. Biosimilars — highly similar versions of approved biological products — can offer a cost-effective, safe and efficacious alternative. However, biosimilars remain highly priced because the path to market is fraught with regulatory challenges.

On March 16, the European Medicine Agency (EMA) adopted its reflection paper on a tailored clinical approach in biosimilar development — an important reform globally. As a result, comparative efficacy studies (CES) — expensive and multi-year clinical trials, for example — will no longer be routinely expected when analytical and pharmacokinetic data demonstrates sufficient biosimilarity. The US Food and Drug Administration also signalled a similar shift, releasing a proposal to eliminate mandatory CES. This reform could reduce biosimilar development timelines from 5-8 years to 2-4 years and save manufacturers millions per product. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had accomplished this as early as 2021; and Health Canada has also issued draft guidelines on removing CES.

In India the Central Drugs Standard Control Organisation had issued draft guidelines on similar biologics in May 2025, introducing advanced analytical methodologies, reduced reliance on animal studies and permitted conditional waivers on Phase III trials. Though progressive, they fall short. The guidelines are discretionary and mandate case-by-case assessment of clinical trial waiver rather than establishing clear, predictable criterion like the EMA and MHRA. Animal studies, while reduced, remain discretionarily required — a step backwards at a time when there is a movement towards non-animal alternative models globally.

Thriving market

India has about 135 approved biosimilars — among the highest globally — with a flourishing biosimilar market valued at about $1.5 billion and growing at 20 per cent annually. Leading manufacturers such as Biocon, Dr Reddy’s Laboratories, Intas, Aurobindo and Zydus export biosimilars to the US, Europe and emerging markets. The government’s ₹10,000 crore Biopharma Shakti mission is designed to position India as a global biosimilar manufacturing hub. With an estimated $200 billion worth of biologics expected to lose exclusivity by 2030, the Indian industry is well placed to capture a significant share.

However, the current guidelines may pose challenges. The arithmetic is stark: mandatory clinical trials cost millions of dollars and years of delay. While global regulators now recognise that, the Indian guidelines retain substantial discretion and lack a clearly defined waiver pathway.

Meanwhile, Indian patients continue to bear the brunt of this regulatory inertia. Biosimilars like trastuzumab have already reduced costs by 60-70 per cent; aligning Indian guidelines with those of the EMA and MHRA could reduce prices further.  A few biosimilars have found their way into Central and State government schemes that provide health insurance coverage; bolder guidelines could dramatically improve that.

India had approved the world’s first biosimilar in 2000, ahead of Europe and the US. It has the manufacturing capacity, the scientific talent and market demand. The Biopharma Shakti mission has set the right direction and CDSCO’s guidelines must now provide the road — built on scientific clarity and not discretion.

(The writer is a Senior Researcher, Third World Network. Views are personal)

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Published on May 18, 2026