Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.
The FDA said Monday it launched the first phase of its improvement to the Purple Book by moving from a list format to a searchable database, so the public can more easily search biosimilar and biologic products.
The list is still available; the FDA said; while the update to the new database continues, the FDA said the static PDF will continue to house information on all FDA-licensed biological products. The initial Purple Book version contains a limited data set that includes all approved biosimilar products and their related reference products, with a simple search and advanced search function.
The FDA said it will also publish a Federal Register notice and open a docket to gather public comment on the database to inform the next phases of development; they will also take user testing and stakeholder input into consideration as additional functionality and improvements are developed and implemented in subsequent phases.
Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products, in addition to enhanced functionality.
Once the new database update is completed, the list/PDF format version will cease updates. The updated database is “intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options, including biosimilar and interchangeable products, and to advance public awareness about licensed biological products,” the FDA said.
“Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.
The new database includes information about FDA-licensed biological products, such as the product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, marketing status, and more. The enhancements also include more information about approved biological products (such as including information pertaining to exclusivity, and whether a product has demonstrated that it is biosimilar to, or interchangeable with, a reference product), intended to help patients and industry track the licensure statuses of biosimilar and interchangeable biological products, and to aid prescribers and pharmacies in identifying life-saving, and potentially cost-effective medications.