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A Biosimilar is essentially a highly similar version of an original biologic medicine, produced by a different manufacturer once the patent for the original product expires. These approved biosimilars are akin to generic versions of biologic drugs, which are derived from animal or plant proteins rather than synthetic chemicals.

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Difference between biosimilars and generics

  • Biosimilars entail creating equivalents of biological entities, while generics involve replicating chemical entities known as Active Pharmaceutical Ingredients (APIs).
  • Biosimilars require engineering organisms to produce the same therapeutic effect, as biological entities may differ somewhat. Generics, on the other hand, can simply produce copies of the API.
  • Biosimilars are more complex than generics in terms of their structure, manufacturing processes, and the data required for regulatory approval.
  • Regulatory approval for biosimilars is more intricate compared to that for generics.
  • Biosimilars are trickier to copy than generics because they’re more complex and can have structural differences.

Prospects of Biosimilars

  • The rise of biologics, especially for cancer, diabetes, and autoimmune diseases, has opened up a worldwide chance for biosimilars.
  • Indian pharmaceutical companies are heavily investing in biosimilar development and production to gain a competitive edge.
  • Zydus Cadila made history in 2014 by launching the world’s first biosimilar of Adalimumab, a drug patented by AbbVie, used to treat rheumatoid arthritis and other autoimmune disorders.
  • Biosimilars offer a more affordable alternative to biologics, which are often priced out of reach for many patients.
  • The expiration of patents on certain biologics, along with upcoming expirations, presents an opportunity to bridge the gap with biosimilars.
  • Biosimilars can help fight diseases like cancer, asthma, and arthritis in poorer nations, boosting public health.
  • Promoting the production of biosimilars and complex generics can contribute to addressing the rising prevalence of non-communicable diseases globally.
  • The biosimilars industry provides a platform for pharmaceutical firms to innovate, thrive, and make money while addressing vital healthcare needs.

Challenges faced

  • Developing biosimilars is costly and time-consuming, with a potential price tag exceeding Rs 100 crore and a timeline of six to seven years.
  • The lengthy development process poses challenges in attracting investors, as a product hitting the market after such a long period may deter interest.
  • The Indian startup ecosystem is unlikely to see significant activity in Biocopies due to the extended development timeline and associated costs.
  • The sector may witness consolidation as smaller players struggle to sustain operations during the lengthy development phase.

Way forward

  • Governments can facilitate growth in the Biocopies segment by establishing clear regulatory frameworks, particularly in countries where regulations are still evolving.
  • China has exemplified this approach by prioritizing biopharma, including Biocopies, and providing support at the governmental level.
  • India can stimulate growth by investing in education and fundamental research to expand the biology research ecosystem.
  • Implementing robust regulatory mechanisms and conducting thorough monitoring are essential to prevent unfair and unethical practices in biosimilar development.
  • By fostering a conducive environment for biosimilar development, governments can contribute to the expansion and accessibility of affordable biologic medicines.

Read also Biological Diversity Act: An Overview

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