On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more
Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more
1/26/2023
/ Biosimilars ,
Canada ,
Double Patent ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inter Partes Review (IPR) Proceeding ,
Obviousness-Type Double Patenting (ODP) ,
Patent Litigation ,
Patent Portfolios ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
UK ,
USPTO
On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The...more
On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab). The BLA includes both subcutaneous...more
On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN. The product will be marketed under the proprietary name ALYMSYS and represents...more
On January 28, 2022, the Food and Drug Administration (FDA) approved Genentech’s VABYSMO (faricimab-svoa) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). According to the...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year...
President Biden Signs Orange Book Transparency Act -
In January, we reported that President Biden...more
12/31/2021
/ Biden Administration ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Guidance Update ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Orange Book ,
Patent Applications ,
Patent Examinations ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book ,
Statutory Requirements ,
Transparency ,
USPTO
On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were...more
12/6/2021
/ Biologics ,
Biosimilars ,
EU ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Information Reports ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drugs