Cementing India's place as global leader in biosimilars

Over the past decade, biologics and biosimilars have taken centre stage in medical advancements. Their potential in treating diseases previously considered untreatable, such as certain types of cancer, autoimmune disorders, and rare genetic conditions, has changed the face of healthcare. India, with its robust biotechnology and information technology sectors, has embraced this shift and is making significant strides in the development and manufacturing of biological drugs.

Biosimilars, also known as follow-on biologics, are the subsequent versions of innovative biological medicine that are introduced after the expiry of the original medicine's patent. The development of biosimilars is a complex and expensive process, but it has potential to improve the accessibility of life-saving treatments. Emerging technological trends in the biosimilar sector are redefining the way these medicines are developed, evaluated, and marketed. Given that India is a global hub for generic medicine, it is critical to examine the country's role in the rapidly evolving biosimilars landscape.

In recent years, the market for biosimilars or similar biologics, has seen significant expansion, particularly in India. India's biosimilars market size was valued at $349 million in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 25.2 per cent from 2022 to 2030 and will reach $2108 million by 2030.

India is one of the leading manufacturers of biosimilars, and has observed an increase in their use, improving the health of many patients suffering from a wide variety of diseases. The most significant advantage of biosimilars is that they cost less than the original drugs that they replicate.

An article noted that the expiration of patents on many key biologics by 2020 would provide a sizable opportunity for the development and use of biosimilars. With over one hundred biopharmaceutical companies engaged in the manufacturing and marketing of biosimilars, India has emerged as a global market leader in this segment. It was the first to approve a biosimilar back in 2000 for the treatment of hepatitis B- much before Europe and the United States.