Interchangeability Evaluations News Today : Breaking News, Live Updates & Top Stories | Vimarsana

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 partnerships for licensing of existing IP; (ii) targets for IPRs; or (iii) design around opportunities for the...

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 Support Biosimilars Market In February, the U.S. Food and Drug Administration and the Federal Trade Com...

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 clai...