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...more
4/26/2021
/ Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
IP License ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Purple Book ,
Small and Medium-Sized Enterprises (SMEs)