25 Transformative Years of BIOSIMILARS

BIOSIMILARS

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2025 marks 25 years since India first ventured into the biosimilar space. Over the past quartercentury, the country has consistently solidified its position as a global leader in biosimilar approvals, with 135 approvals till January 2025. Initially focused on simpler biologics, the field now includes developing and approving complex monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), a diversified therapeutic focus, and a growing number of innovative players entering the field. As the industry celebrates this silver jubilee, we reflect on the journey that has not only transformed India's biotechnology sector but has also played a pivotal role in making lifesaving treatments more accessible and affordable worldwide.

The first ‘similar biologic’ was approved and marketed in India for a hepatitis B vaccine in 2000, well ahead of the EMA's (European Medicines Agency) approval in 2006 and the US FDA's (United States Food and Drug Administration) approval in 2015 for biosimilars for export. Since then, the biosimilars landscape in India has grown leaps and bounds. As of January 2025, India has approved 135 biosimilars across various continents, far surpassing the approvals in the US FDA and EMA. The Indian biosimilars market was valued at approximately Rs 4.37 billion in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 14.2 per cent, reaching around Rs 16.49 billion by 2034 as per Expert Market Research.

Talking about therapeutic trends,