Feel free to discuss and ask me any questions! I am currently doing research at the University of Texas in Austin College of Pharmacy about the cost effectiveness of biosimilars! Also let me know if you would like resources to learn more about biosimilars! 😀 The following is an introduction to my literature review on biosimilars.
What are biosimilars?
Biosimilars are continuing to be an emerging trend among the pharmaceutical world. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. Since the passing of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, it has accelerated the development of biosimilar products by creating an abbreviated licensure pathway to demonstrate biosimilarity or interchangeability to a reference biologic. Biologics account for about 5% of total health care spending but less than 1% of customers utilize these drugs in the US. The average biologic costs about 40 times more than the average non-biologic drug which makes it a significant point of interest and conflict involving both its cost and utilization. This is the major driving force for development of new biosimilars.
How are biosimilars approved?
The FDA looks at a vast variety of data when approving a biosimilar. The approval process for biosimilars is rigorous, heavily relying on pharmacokinetic and pharmacodynamic studies along with analytical chemistry data, to ensure its efficacy, safety, and quality. Furthermore, clinical trials are required to show the biosimilarity between the proposed product and its reference biologic. For an interchangeable product, additional studies showing that the biosimilar can produce the same clinical results as the reference in any given patient and that switching between the proposed interchangeable product will not cause a decrease in safety or efficacy are required.
Costs and Patents
The cost of producing a biosimilar is estimated to be around $100 to $250 million dollars. Comparing the cost of a biosimilar to its reference product, there is a reduction of 35% to 45%, allowing it to be more competitively priced. Biosimilars hopefully create a competitive market for innovating companies to develop new biologic products, drive cost reduction, and eventually increase patient access. However, the BPCIA currently provides manufacturers a 12-year exclusivity period from the date of licensure for the originator biologic product which limits the amount of biosimilars that can be introduced to the market. As the time comes in the next few years, more than 50% of the biologics patents will expire. Despite that, manufacturers have opportunities to evergreen their patents for additional exclusivity duration and challenge the launch of biosimilars through litigation. Many issues currently surrounding the development and utilization of biosimilars exist as early in the process as manufacturing the biosimilar to the launch phase of the product and beyond. In addition to complexity in developing and litigation, physician and patient acceptance pose further challenges once the product is FDA-approved.
How are biosimilars developed and regulated in your country? What are your thoughts and opinions about the emerging trend of biosimilars on the market?