FDAnews
www.fdanews.com/articles/188608-drug-companies-call-for-interchangeability-information-in-purple-book

Drug Companies Call for Interchangeability Information in Purple Book

October 1, 2018

Several leading drugmakers — including Janssen, Novo Nordisk and Genentech — urged the FDA to include new information on interchangeable products in the agency’s Purple Book, which lists biological products including biosimilars and interchangeables licensed by the agency.

In written comments to the agency following a Sept. 4 public meeting on biosimilars and interchangeable products, Johnson & Johnson subsidiary Janssen suggested adding the following language about shifting patients from reference to interchangeable drugs:

“FDA has determined that it is safe to switch patients from a reference product to an interchangeable product, and the laws in many states permit substitution of interchangeable products for their reference products at the pharmacy level under certain conditions (check your state’s laws and regulations). FDA has not made such a determination about a product approved as a biosimilar; pharmacy-level substitution is not advised and may be illegal under state law. In addition, FDA does not make such determinations regarding switching between two or more biosimilar products, whether interchangeable or not, and often there are little or no data regarding such switches.”

View today's stories