The enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010 established for the first time ever in the US an abbreviated pathway for obtaining FDA approval of a new biological product that is deemed...more
7/14/2020
/ Biosimilars ,
BPCIA ,
Corporate Branding ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Protection ,
Litigation Strategies ,
Patent Prosecution ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions
On February 6, 2020, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance (“Guidance”) that addresses the licensure of a biosimilar or biosimilar interchangeable product for fewer than all of the conditions...more
2/13/2020
/ aBLA ,
Biosimilars ,
BPCIA ,
Carve Out Provisions ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
IP License ,
Labeling ,
Licensing Rules ,
Life Sciences ,
Orphan Drugs ,
Pharmaceutical Industry
On April 28, 2015, FDA released three final versions of guidance documents relating to biosimilars that were initially released in February 2012. One of the guidances provided Questions and Answers regarding implementation of...more