As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
1/3/2023
/ America Invents Act ,
Biden Administration ,
Biosimilars ,
China ,
Drug Pricing ,
EU ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Governor Newsom ,
Interchangeability ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Purple Book ,
USPTO
On December 22, 2022, Celltrion USA announced that it submitted a Biologics License Application (BLA) for a subcutaneous formulation of infliximab, CT-P13, to the U.S. Food and Drug Administration (FDA). According to...more
As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its biosimilar’s (YUFLYMA)...more
On March 7, 2022, the US Food and Drug Administration (FDA) issued a Funding Opportunity Announcement (FOA) to commit up to $5 million in fiscal year 2022 toward several research proposals. Specifically, the FDA anticipates...more
On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration. FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is...more