Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have launched in the U.S. market....more
In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more
4/8/2024
/ Biologics ,
Biosimilars ,
BPCIA ,
Drug Approvals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
USPTO
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
On November 17, 2017, Genentech filed suit against Pfizer in the District of Delaware, alleging that Pfizer’s biosimilar of Herceptin® infringes forty Genentech patents covering Herceptin® and its methods of use and...more
11/24/2017
/ Biosimilars ,
BPCIA ,
Genentech ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents