Biosimilars landscape in India

Harleen Kaur, Senior Research Scientist, Aurobindo Biologics, believes that entering and working in the biosimilar arena, particularly in India and other emerging markets, could be a great learning curve for companies, scientists and investors entering into this field

There is a pressing need for the biologic drugs in the global healthcare to address the unmet need in multiple therapeutic areas, particularly in oncology, nephrology, immunology, diabetes and others. India is a leading player in the biosimilars market at global level. Domestic Indian companies such a Biocon, Dr Reddy’s, Intas Pharmaceuticals, Hetero Pharma, and Lupin Pharmaceuticals are few of the key players with the largest number of products launched in the country as well as in other emerging economies. Moreover, with growing interest in biosimilars in the Indian landscape, many new companies, including startups such as Enzene Biosciences, are also jumping on the biosimilars bandwagon.

So, what are Biosimilars?
Biosimilars, also known as biogenerics or follow-up biologics, are replicas of innovator drugs that are produced from living organisms. However, analytical studies that compare innovator biologics and biosimilars often report differences in aggregate levels, charge variant, protein concentration, glycosylation, stability, conformational states, and bioactivity1,2.
Unlike generic drugs (commonly referred to as ‘small molecules’ in pharma), biological molecules are inherently complex and are sensitive to changes in development and manufacturing process.

  • The greatest challenges in developing biosimilars are:
    Establishing their similarity with the original medicine, finding the original molecular clone,
  • Optimising the upstream and purification process,
  • Developing biosimilar manufacturing capability along with overall high cost of development,and
  • Dealing with stringent and lengthy regulatory pathways in various countries.

Despite this, I believe entering and working in the biosimilar arena, particularly in India and other emerging markets, could be a great learning curve for companies, scientists and investors entering into this field. To date, there are more than 40 biosimilar products in Indian market and several of them are active in the pipeline. 15 epoetin, 8 G-CSF, 4 insulin and more than 10 domestic large-sized companies are competing in this area.

Few of the approved and marketed bisimlar drugs have been highlighted in Table 1 along with their respective indication, approval year and company’s name. With so many biosimilars in market, Indian companies and drug regulators could provide valuable lessons about what it takes to enter and establish a thriving biosimilars market in terms of accessibility, investments, competition, regulatory strategy, and other facets to other countries across the globe.

Table1: List of approved biosimilars product launched by Indian companies

Of late, Indian biopharmaceutical companies have seen a significant number of patients being served year on year at lower drug prices through their biosimilar portfolio. In fact, they are seriously focusing on the development and marketing of biosimilars not only in emerging nations, but in developed countries as well. With 20% share being anticipated by the Indian pharma market in global scenario for the next decade, and many biologic drugs patents expiring in the next few years, the Indian pharmaceutical industry foresees a tremendous potential to generate great profits, beckoning a promising growth and investment opportunities in biosimilars market in the future.

1. Seo N, Polozova A, Zhang M, Yates Z, Cao S, Li H, Kuhns S, Maher G, McBride HJ, Liu J. Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab. (2018). MAbs. 10(4):678-691.
2. Strand V, Girolomoni G, Schiestl M, Ernst Mayer R, Friccius-Quecke H, McCamish M. The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar. (2017). Curr Med Res Opin. 33(6):993-1003.
3. and-marketed-in-India