An Introduction To The Biosimilars And Their Existing Market

A replication of their parent biopharmaceutical developers, biosimilars are biological products that have similar biopharmaceutical manufacturing and structural complexities as of biologics. However, there is a difference.

Biologics are compound and large proteins made of living cells, while biosimilar are a non-identical copy of the original medicines with similar properties.

Out of the 69 authorized biosimilars in Europe, 54 are granted approval to access the healthcare market. In the US on the other hand, 31 FDA-approved biosimilars circulate the healthcare market. 

Both the FDA and the EMA have strict guidelines for demonstrating the biosimilarity of biosimilars. The guidelines are derived from both vivo and vitro data. For demonstration, there is a comparative evaluation required by the WHO that includes factors like impurities, biological activity, physicochemical properties, and stability of the biosimilars. In Europe, the European Medicines Agency governs the licensing of biosimilars, while in the US, the regulation of biosimilars and biologics follows the Biological Price Competition and Innovation Act (BPCI Act).

Key pharmaceutical companies in the biosimilar market include Celltrion, Boehringer Ingelheim Pharmaceuticals, Pfizer, Sandoz, Mylan Pharmaceuticals, Samsung Bioepis, and Amgem along with others.

Approved Biosimilars In The US Market:

• Remicade (Infliximab) Biosimilars.
• Humira (Adalimumab) Biosimilars.
• Rituxan (Rituximab) Biosimilars.
• Enbrel (Etanercept) Biosimilars.
• Lucentis (Ranibizumab) Biosimilars.
• Neupogen (Filgrastim) Biosimilars.
• Avastin (Bevacizumab) Biosimilars.

The demand for healthcare has been increasing and there are many novel approaches being developed to treat various conditions. All of this has led to the development of stringent changes to take place in the biosimilar approval market. The recent expiration of biologic drugs, will further the growth of the biosimilar market. Consequently, many pharmaceutical companies have been inspecting the biosimilar market for new opportunities.

Due to their cost-effectiveness, medicines like biosimilars will help in reducing the mounting burden on healthcare due to rising prevalence of disorders around the globe.

Source: US and EU Biosimilar Market – Approved Biosimilar and Key Companies – By Delveinsight.