The research was conducted by the US Food and Drug Administration’s (FDA) Office of Therapeutic Biologics and Biosimilars and the Division of Biometrics VIII of the Office of Biostatics, both within the Center for Drug Evaluation and Research (CDER). It was published in the October 3, 2023, issue of PLOS One.
Biosimilars are increasingly available for the treatment of many serious diseases and disorders. However, some concerns had been theorized about switching a patient whose condition had been stabilized while using the reference biologic to a biosimilar. These theoretical concerns have now been laid to rest in the first systematic review using statistical methods to assess the risk of switching patients. This review found no differences in the safety profiles or immunogenicity rates between patients who were switched and those who remained on the reference biologic.
Under the Biologics Price Competition and Innovation Act (BPCIA), FDA only allows an interchangeable classification to be added to a biosimilar’s labeling if extensive (and expensive) switching and alternating studies were submitted in the Biosimilar approval application. This has greatly stifled the development of biosimilars, which are lower-cost alternatives to name brand biologics. The new published study finds that such studies are essentially unnecessary and redundant. Since the interchangeable labeling classification is included in the BPCIA, legislative action would be needed to remove this classification; however, given the conclusions in this study, the FDA could use its authority to declare that all biosimilars are interchangeable with their name brand counterparts.