2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
1/12/2022
/ America Invents Act ,
Antitrust Provisions ,
Biden Administration ,
Biologics ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Executive Orders ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
New Guidance ,
New Legislation ,
Orange Book ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Post-Grant Review ,
Prescription Drugs ,
Regulatory Requirements ,
USPTO
Eight years have passed since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), and the biosimilars industry has continued to grow. In 2018, seven biosimilar drugs were approved by the U.S. Food...more
1/15/2019
/ Biosimilars ,
BPCIA ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular