FDA 'reviewing options' for biosimilar list

FDA said it is "reviewing options for making a publicly available list of licensed biosimilar products and interchangeable products," but the agency said it does not have a timeline for publishing the list. The agency also said it is "too early" to say whether the list will also contain patent and exclusivity information for innovator biologics. John Jenkins, director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research, said earlier this week that the agency was planning to develop a guide like the Orange Book for biologics. The Orange Book lists all approved generic equivalents for a drug, along with its patent and exclusivity information. ...