Use of Identical INN "Imiglucerase" for Different Drug Products: Impact Analysis of Adverse Events in a Proprietary Global Safety Database.

The objective of this study was to assess the consequences of multiple drugs using the identical International Nonproprietary Name (INN) "imiglucerase" on adverse event reporting in the Sanofi Genzyme Global Safety Database. The World Health Organization established the INN system to identify drugs that are made of the same pharmaceutical substance and recommends that different products have distinct INN names. The INN imiglucerase was assigned in 1994 to Cerezyme^® (Sanofi Genzyme), an orphan drug for the treatment of a rare disease known as Gaucher disease. In 2015, Asbroder^® (ISU Abxis) was approved for Gaucher disease in Mexico and has adopted the INN imiglucerase. It was not approved as a biosimilar to Cerezyme. Most importantly, in a significant proportion of the adverse event cases reported, patients received a combination therapy of Asbroder and Cerezyme or Asbroder and "imiglucerase", suggesting that the shared INN may have led to misconceived interchangeability of these products. Such confusion among healthcare providers poses a potentially serious risk to patient safety and health. These results are especially worrisome because they relate to products sharing an INN that were not approved as biosimilars. The findings from this study are also consistent with the view that Cerezyme and Asbroder may have different safety profiles. The implications of drug products having the same INN are discussed in the article as well as recommended solutions. To our knowledge, this is one of the first reports on real-world safety experience with biologics sharing the same INN name.