Will purple become the new orange? The new FDA purple book for biologies: what does the future hold?

摘要

Some fashion trends may come and go, but in the not too distant future the majority of prescription drug sales will be purple. For those of you not yet familiar with this latest trend, allow us to explain. In September 2014, the US FDA published its first edition of the so-called 'Purple Book,' with the rather lengthy title - 'Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.' This new publication, like its well-established 'Orange Book' counterpart, will list approved biologic drug products and also their biosimilar and interchangeable generic equivalents. However, the Purple Book is still in its infancy. As of this writing, the published information is far from complete. Furthermore, the FDA has been slow in publishing the necessary guidance documents.