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Patent Transparency For Biologics Biosimilars The Revamped Purple Book

Patent Transparency For Biologics Biosimilars The Revamped Purple Book
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Taking Advantage of the New Purple Book Patent Requirements for Biologics | Morgan Lewis

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New federal legislation will take effect this year that will require a reference product sponsor to submit to the FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to list these patents in the Purple Book. Small and medium-sized enterprises (SMEs) and others in the industry can take advantage of this new source of information by using it to identify (i) potential partnerships for licensing of existing IP; (ii) targets for IPRs; or (iii) design around opportunities for the development of new technology. ....

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

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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 ....

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Legislation Requiring Greater Disclosure by Pharmaceutical Brands

Monday, December 21, 2020
Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if enacted, will require brand pharmaceutical companies to submit more information about their innovator products.
Potential Changes to Orange Book Listing Requirements for Non-Biologics Drugs
As part of its current obligations, an innovator product manufacturer must submit to the FDA the patent number and expiration date of any patents that claim the drug or a method of using the drug. The FDA then performs the ministerial function of listing the information in the ....

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