Print Friendly, PDF & Email

Biosimilar medicine

Topics Covered:

Awareness in the fields of IT, Space, Computers, robotics, nano-technology, bio-technology and issues relating to intellectual property rights.

Biosimilar medicine

What to study?

For Prelims: About Trastuzumab, What are Biosimilars?

For Mains: Significance and the need for Biosimilars.

Context: WHO prequalifies first biosimilar medicinetrastuzumab- to increase worldwide access to life-saving breast cancer treatment.

  • Trastuzumab – a monoclonal antibody – was included in the WHO Essential Medicines List in 2015 as an essential treatment for about 20% of breast cancers.


Breast cancer is the most common form of cancer in women. 2.1 million women contracted breast cancer in 2018. 630 000 of them died from the disease, many because of late diagnosis and lack of access to affordable treatment.

For Prelims:

What are Biosimilars?

  • It is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
  • They are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent expires.
  • Reference to the innovator product is an integral component of the approval.


  • Biological medicines contain active substances from a biological source, such as living cells or organisms.
  • Most biological medicines in current clinical use contain active substances made of proteins.

Difference between biosimilars and generics:

  • Biosimilars involve developing equivalent of biological entitywhile generics involve developing equivalent of a chemical entity-the Active Pharmaceutical Ingredient.
  • Cost: Generic drugs are chemically identical to the original branded drug and, as such, cost significantly less because they don’t require much testing. Because biosimilars are made from living organisms, though, and don’t contain identical ingredients to their name-brand counterparts, they still require some testing. So, they cost more than generics, but less than the branded biologic.

Value addition for Mains:

Need of the hour:

  • Biosimilars industry can act as a springboard for the pharma cos to innovate, excel and earn profit and the same needs to promoted at the earliest.
  • we need to increase access through affordable pricing and some of the drugs need to be under price control.
  • Governments can support growth in production of complex generics and biosimilars by clarifying the regulatory framework for them, which is still evolving in many countries.


Sources: the Hindu.