Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

By Lynn L. Bergeson

On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted sections reflecting changes made in the previous month. This is the second phase of FDA’s Purple Book planned improvements.

As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their reference products. The first phase of the upgrade included information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of the methodology was reviewed by an outside consultant, contracted by FDA. The report summarizes the evaluation of FDA’s proposed capacity planning adjustment methodology to calculate the annual fees for human drugs and biosimilar biologics under the FDA Reauthorization Act of 2017. According to the report’s executive summary, “[t]he report examines the options and recommendations for the proposed capacity adjustment methodology to accurately assess changes in the resource and capacity needs for prescription drug and biologic biosimilar fee direct review work.” Relevant to those interested in developing, and streamlining such products, as part of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and Biosimilar User Fee Amendments of 2017 (BsUFA II) commitments, FDA is developing this methodology to improve its user fee resources. Comments will be accepted until May 6, 2020.

Tags: FDA, Biologic

 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. Established in 2009, the Biologics Price Competition and Innovation Act (BPCI Act) deemed applications for an approved biological product under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to be a license for the biological product under Section 351 of the Public Health Service Act (PHS Act) as of March 23, 2020. Aiming to make the BPCI Act implementation process smoother, FDA has published the guidance for industry as part of the “transition” provision of the Act. The transition of biological products currently regulated under the FD&C Act to the PHS Act will allow for the submission and approval of marketing applications for new biosimilar or interchangeable biological products. The guidance follows FDA’s recent issue of the new definition of the term “biological product,” announced on February 21, 2020, per Bergeson & Campbell, P.C.’s (B&C®) February 28, 2020, blog item.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On March 5, 2020, FDA opened a public docket for comments on its enhancement of the Purple Book, which is otherwise known as FDA’s “Database of FDA-Licensed Biological Products.” As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their reference products. These upgrades will be released in multiple phases. FDA has now completed phase I, which consists of the full search functionality of the database. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products.

The first phase of the upgrade includes information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. Given its completion, FDA is now requesting comments from stakeholders until May 4, 2020.


 

By Lynn L. Bergeson

On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases, the full search functionality is the first step. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products. The aim is to grow the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products.

The first phase of the upgrade includes information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. FDA plans to open a public docket to gather feedback from stakeholders on the new database with its enhanced functionality. In the announcement, Dr. Hahn stated that “[t]his expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.”


 

On November 29, 2016, Green Biologics, Inc. (Green Biologics) announced that its high purity biobased n-butanol and acetone received certification under the U.S. Department of Agriculture’s (USDA) BioPreferred® program.  Both products, which are produced through the fermentation of sugars from renewable feedstocks, were certified as 100 percent biobased.  In the early stages of its first commercial production facility, Green Biologics aims to produce commercial n-butanol and acetone by late 2016.  Additionally, Green Biologics states that the production of its renewable n-butanol results in 85 percent lower carbon emissions than alternative petroleum-based sources.
 
The BioPreferred program is a USDA initiative to increase the purchase and use of biobased products through mandatory purchasing requirements for federal agencies and contractors, and voluntary product certification and labeling.  The USDA Certified Biobased Product label is designed to help consumers identify biobased products containing a verified amount of renewable biological ingredients.