On June 21, the FDA withdrew draft guidance for industry entitled ‘Statistical Approaches to Evaluate Analytical Similarity.’ The guidance, issued in September 2017, was met with concern among developers who claimed that it could adversely impact both cost and efficiency of development. By acting on industry concerns and withdrawing the guidance, the FDA has highlighted its commitment to promoting the development, and ensuring availability, of biosimilars as it strives to catch up with the other six major markets (the 5EU [France, Germany, Italy, Spain, UK] and Japan). Given the rising cost of healthcare as innovative medicines become more expensive and more widely used, providing access to biosimilars will be crucial for the major economies to achieve sustainability.
Despite 11 biosimilar products having been approved by the FDA since 2015, the US significantly lags behind the 5EU and Japan in terms of bringing biosimilars to market, due to significant educational, financial, and legal barriers. Although the FDA’s draft guidance issued in 2017 showed its willingness to accelerate biosimilar development, the Association for Accessible Medicines was concerned that the 10 reference ‘lots’ recommended to be sampled to establish similarity, as well as the need to source all reference lots from the US, would make the development of biosimilars too costly and time-consuming. Given that a key driver for the biosimilar market is to provide cost savings, these issues could have dissuaded biosimilar developers from pursuing US development.
The FDA intends to release a new draft guidance shortly, aiming to address the issues raised as well as the challenges faced by developers when designing a clinical trial to evaluate similarity, particularly when considering variation between lots of all biologics. With the global sales of biosimilars estimated to reach $99.28B by 2024, and with significant cost savings being demonstrated around the world, it is clear that the US market could benefit from enabling access to biosimilars. The FDA’s willingness to address industry concerns by withdrawing potentially problematic advice, as well as its keenness to steer and encourage developers to produce biosimilars by providing new guidance, showcases a step in the right direction, bringing the biosimilars market ever closer to success in the US.