Context: WHO prequalifies first biosimilar medicine– trastuzumab- 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.

Background:

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.

Characteristics:

• 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: