Biosimilars

Biosimilars are biological medical products that are highly similar to existing approved biological medicines, known as reference medicines. Biosimilars are usually made from living organisms that are majorly found in plant and animal cells. Biosimilars are officially proven versions of innovator products and are manufactured upon the expiry of patents of the original products. The World Health Organization (WHO) has Biosimilars are biological medical products that are highly similar to existing approved biological medicines, known as reference medicines. Biosimilars are usually made from living organisms that are majorly found in plant and animal cells. Biosimilars are officially proven versions of innovator products and are manufactured upon the expiry of patents of the original products. The World Health Organization (WHO) has published guidelines for the evaluation of similar biotherapeutic products (SBPs) to provide international norms for conducting clinical trial for manufacturing and development of biosimilars with a high degree of similarity across various geographies. The European Union (EU) was the first in the world to develop a regulatory and legal scientific framework for the approval of biosimilar medicines. The US Food and Drug Administration (FDA) followed the adoption of biosimilars through legalizing their use and approving biosimilars safe for human use in 2015. As biosimilars are not identical copies of their reference drugs, these are not classified as generic drugs. Although exact same materials and procedures are used to produce these drugs, there might be slight variations between batches. The biosimilars are used in the treatment of diseases such as various types of cancer and severe chronic neutropenia. The approval of these medications by governing bodies make them more accessible for people from low- and middle-income groups, which accelerates their sales, benefiting both drug-makers and patient populations. As per records for June 2020, the European Union (EU) has the largest number of approved biosimilar medicines. Some of the syndicate studies by The Insight Partners for biosimilars include Biosimilars Market, Human Insulin Market, and others.

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