“US FDA Biosimilar Regulatory Developments in 2020”- Dr. Fiona Greer

Despite the pandemic, last year the US FDA worked through several issues which impact biologics and biosimilars, and I thought that it would be worthwhile looking at some of these.

In fact, last February was a very busy time! The first development was an announcement on Feb 3rd of a collaboration between the FDA and the Federal Trade Commission aimed at “supporting appropriate adoption of biosimilars, discouraging false or misleading statements and deterring anticompetitive behaviors in the biologic marketplace”. A public workshop held in March to discuss this issue can be viewed online (1).

Also in February, the FDA issued its Final Rule regarding the definition of a “biological product” (2). This defines a protein as “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.” Importantly it addressed the transition of products previously regarded as small molecules, such as Insulin and Somatropin, to biologics.

Later that same month, it then launched an online, searchable database version of the so called “Purple Book”- a “List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity and Interchangeability Evaluations” (3). Draft guidance documents were also issued concerning “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products” and “Biosimilars and Interchangeable Biosimilars: Licensure For Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed”.

Biosimilar Interchangeability

FDA Biosimilar Approvals

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