Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2020

As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020.  Please keep an eye out this week for posts identifying the most important regulatory, market, and legal developments impacting biosimilars.  We start today with our picks for the most significant U.S. regulatory developments related to biosimilars in 2020:

1. FDA and FTC Announced Collaboration to Support Biosimilars Market

In February, the U.S. Food and Drug Administration and the Federal Trade Commission released a joint statement signaling collaboration to advance competition in the market for biologic products. According to the FDA press release, “[t]his joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.”  In March, the two agencies held a public workshop to discuss their collaborative efforts.

2. New FDA Draft Guidance Documents

The FDA issued two draft guidance documents relevant to biosimilars in February.  First, the FDA issueddraft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” This draft guidance addresses the truthful and non-misleading manner in which data and information concerning reference or biosimilar products must be presented. Second, the FDA issued a draft guidance titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”  In November, the FDA released an additional draft guidance on this topic entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.”  According to the FDA, the draft guidance is “intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.”

3. FDA Launch of Searchable Purple Book

In late February, the FDA launched the online version of the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” colloquially known as the “Purple Book.” The searchable database contains information about FDA-licensed biological products, specifically, licensed biosimilar and interchangeable products and their reference products.

4. FDA Issued Final Definition of “Biological Product”

Also in February, the FDA issuedfinal rule regarding the definition of “biological product,” which interpreted the word “protein” to mean “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.”  The FDA stated that this new interpretation “will reduce regulatory uncertainty” by adopting a “‘bright-line’ approach” that “will reduce the amount of time spent by FDA staff and industry” in determining whether a product is a biological product.

This final rule also addressed the transition of insulin, and some other products such as human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropinalfa, and menotropins, from regulation as small molecule drugs to biologics.

5. Impact of Covid-19 Pandemic on Biosimilars

It would not be a 2020 year-end post without mentioning the impact of the Covid-19 pandemic on biosimilars.  Due to travel restrictions, the FDA was unable to complete inspections of manufacturing facilities, leading to delays in approval of Revance’s DaxibotulinumtoxinA for Injection biologic and deferred action on Spectrum’s ROLONTIS (eflapegrastim) BLA.