Seminars in arthritis and rheumatism
-
To provide an overview of the underlying scientific principles and standards for developing a biosimilar product. ⋯ The rigorous and highly regulated processes required to develop a biosimilar have been designed as such to establish a high degree of biosimilarity with a reference product in terms of the structural, functional, biological, and clinical attributes.
-
To discuss current terminology and the regulatory standards and processes involved in the development of biosimilars. ⋯ The addition of biosimilars to the market has the potential to improve access to biologic therapies. Many regulatory agencies have enacted stringent pathways, which must be followed for a biosimilar to be labeled and approved as such; following the pathways will help protect and maintain the integrity, quality, and safety of the biosimilar product.