The biosimilars market is robust and, with continued progress, the savings to patients soar. According to FDA, there are currently 40 licensed biosimilar products and 3 interchangeable biosimilars, 24 of which are currently marketed. And since October of 2021, these products have captured between 3-89% of the market share, depending on the product. With several Humira biosimilars expected to be on the market very soon, the increasing benefit to the public cannot be denied.

The FDA is taking the next logical step in its Biosimilar program and looking to improve the efficiency of product development and advance the approach to interchangeability determinations, which usually requires a switching study.  FDA has, however, approved certain products as interchangeable without such a switching study based on complex analytical characterization along with in vitro data that support the FDA’s knowledge of these products.

According to the Agency “[T]he roadmap highlights research areas where advancement is expected to impact science-based recommendations and regulatory decision making. Specifically, the research areas aim to:

1) Increase the accuracy and capability of analytical (structural and functional), and chemistry, manufacturing, and controls characterizations

2) Develop alternatives to and/ or reducing the size of studies involving human subjects

The FDA hopes to evaluate data from the program along with evaluation of real-world data to make the biosimilar development process more efficient, and to leverage the analytical and scientific advances gained to date to capture those attributes that have the potential to lead to faster approvals by establishing research priorities that result in regulatory impact, and perhaps limit unnecessary human testing. Sound familiar? This is the same concept upon which generic drug development is based.

The program is outlined in the FDA’s BsUFA III Regulatory Research Pilot Program: RESEARCH ROADMAP which can be found here. All in the biosimilar field will anxiously be waiting to see the results of the pilot program and hope that the findings will be translated into speeding up the drug development timeline and the regulatory approval process.