Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
3/11/2025
/ Biosimilars ,
BPCIA ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Intellectual Property Litigation ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Welcome to Venable’s BiologicsHQ Monthly Injection – August 2024...more
8/27/2024
/ Biosimilars ,
Chevron Deference ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Inter Partes Review (IPR) Proceeding ,
Loper Bright Enterprises v Raimondo ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
5/1/2024
/ Biden Administration ,
Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On January 31, 2023, Amjevita™ (adalimumab-atto) entered the U.S. market as the first biosimilar of Humira® (adalimumab), after receiving approval in September 2016. Amjevita will be available in a low-concentration,...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
12/9/2022
/ Biosimilars ,
Clinical Trials ,
Drug Pricing ,
EU ,
European Medicines Agency (EMA) ,
Expedited Approval Process ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
UK
On September 19, 2022, the European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA) issued a joint statement explaining their scientific rationale for determining that biosimilars approved in the EU...more
Cimerli™ (ranibizumab-eqrn) was FDA approved on August 2, 2022 as interchangeable with Lucentis® (ranibizumab). Cimerli is the third interchangeable biosimilar approved in the US, following Semglee® (insulin glargine-yfgn),...more