On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
5/12/2025
/ aBLA ,
Biosimilars ,
BPCIA ,
Celltrion ,
Drug Pricing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Fresenius ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Legislative Agendas ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Legislation
Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more
7/10/2024
/ Biologics ,
Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book
According to a May 1, 2024 press release, the high-concentration (100 mg/mL), citrate-free formulation of Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) was approved by the FDA on May 1 as interchangeable with AbbVie’s...more
According to an April 2024 press release, Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). ...more
On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)...more