Updates to the Purple Book: Database of Licensed Biological Products Today, FDA made updates to the Purple Book: Database of Licensed Biological Products (Purple Book) to publish patent lists that reference product sponsors have provided for certain licensed biological products. Among other things, the Biological Product Patent Transparency (BPPT) section of the Consolidated Appropriations Act of 2021 requires publication of patent lists provided by reference product sponsors (i.e., biologics license application (BLA) holders) to FDA for certain licensed biological products. Specifically, a reference product sponsor is required to provide to FDA the list of patents and corresponding expiry dates, not later than 30 days after the reference product sponsor has provided the initial list to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the Public Health Service (PHS) Act. The reference product sponsor is also required to provide to FDA any subsequent or supplemental lists, and their corresponding expiry dates, within 30 days of the provision of such lists to a 351(k) applicant under section 351(l)(3)(A) or (l)(7) of the PHS Act. FDA's role in publishing patent information is ministerial, and FDA does not consider the applicability of patents to a biosimilar product (e.g., validity, enforceability, or potential infringement) in publishing the information described in section 351(k)(9) of the PHS Act, nor in FDA's review of a 351(k) BLA or supplement to a 351(k) BLA. For additional information regarding Purple Book listing requirements, see FAQ 5. For detailed information regarding submission processes for initial and updated patent information, see FAQ 6 and FAQ 7, respectively. The Purple Book database contains information about all FDA-licensed biological products, including licensed biosimilar and interchangeable products, and their reference products, and information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products. The Purple Book is intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options. |
No comments:
Post a Comment