The Biological Product Patent Transparency Act (“BPPT”)
1 – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the first-ever provision requiring public listing in the FDA’s “Purple Book” of certain patents associated with biologic drug products (
e.g., monoclonal antibody products and other protein drug products). See the text of the BPPT here.
The BPPT sidestepped some of the more controversial approaches to biologics patent listing, by piggybacking off of the patent lists that reference product sponsors (
i.e., biologics innovators) are already required to exchange with biosimilar applicants
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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 t