Interchangeability Evaluations News Today

To embed, copy and paste the code into your website or blog: 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 partnershi...

To embed, copy and paste the code into your website or blog: 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 Sup...

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 produc...