On July 18, 2018, the FDA released a Biosimilar Action Plan[1] that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish these goals:[2]

Improving the efficiency of the biosimilar and interchangeable product development and approval process;
Maximizing scientific and regulatory clarity for the biosimilar product development community;
Developing effective communications to improve understanding of biosimilars among patients, providers, and payers; and
Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.

Notably, the FDA believes that “some of these actions can be transformative for sponsors’ ability to bring high quality biosimilars to market.” The FDA is seeking greater partnership with regulatory authorities in Europe, Japan and Canada, and will be evaluating updates to the Purple Book with additional information to increase transparency. The Purple Book is more formally known as “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” and lists biosimilar products approved or licensed by the FDA (an equivalent to the FDA’s Orange Book, which lists approved small molecule drugs).[3]

The FDA also announced that on September 4, 2018 it will hold a public hearing on the FDA's approach to enhancing competition and innovation in the biological products marketplace, which includes facilitating greater availability of biosimilar and interchangeable products.[4] The FDA released a number of questions soliciting public input on how the agency can work within the existing statutory framework to expand the availability of biosimilar products without compromising scientific standards.

It is interesting to note that the Biosimilar Action Plan and public hearing were announced shortly after the FDA withdrew its draft guidance entitled “Statistical Approaches to Evaluate Analytical Similarity” on June 21, 2018.[5] It has been reported that this withdrawal by the FDA was the result of a citizen petition filed by Dr. Sarfaraz Niazi, an adjunct professor at the University of Illinois.[6] In his petition, Dr. Naizi discussed the need to re-evaluate the scientific rationale behind the current methods of testing biosimilarity – with the aim of reducing barriers, such as redundant analytical testing and testing in humans, without compromising quality. A second premise proposed by Dr. Niazi was to invoke new technologies to establish similarity between biosimilars and the reference product to facilitate faster biosimilar approvals. Additional suggestions by Dr. Niazi included waiving bridging studies for qualified non-U.S. reference product, and developing a system for making reference samples more freely available to biosimilar makers.[7]

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[1] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613881.htm

[2] https://www.centerforbiosimilars.com/news/fda-to-hold-public-hearing-on-biosimilar-action-plan

[3] http://www.haynesboone.com/~/media/files/alert%20pdfs/fdapurplebookvorangebook.ashx

[4] https://www.federalregister.gov/documents/2018/07/25/2018-15859/facilitating-competition-and-innovation-in-the-biological-products-marketplace-public-hearing

[5] https://www.fda.gov/Drugs/DrugSafety/ucm611398.htm

[6] https://www.forbes.com/sites/nicolefisher/2018/07/25/one-mans-mission-to-fix-the-fdas-biosimilar-problem/#1a4e393b2380

[7] https://seekingalpha.com/news/3367537-fda-withdraws-draft-guidance-related-biosimilar-development

Written by: Daniel A. Kamkar and Jane Dai, Ph.D.