2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
1/23/2023
/ Antitrust Provisions ,
Biosimilars ,
BPCIA ,
Competition ,
FDA Approval ,
Food and Drug Administration (FDA) ,
New Legislation ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Post-Grant Review ,
Prescription Drugs ,
Regulatory Requirements
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
Introduction - The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. Yet 2020 saw a slowdown in biosimilar activity with the lowest number of annual biosimilar approvals since...more
2/5/2021
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
This post is a part of a monthly series summarizing notable activity in patent litigation in the District of Massachusetts, including short summaries of substantive orders....more