On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).
Under...more
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the...more
6/22/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Treatment ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Revocation ,
Secretary of HHS
The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight and...more
The BPCIA and the Debate Over Naming Biosimilars -
Most drugs on the market today are small-molecule compounds with active pharmaceutical ingredients that can be duplicated to create “generic” drugs. It is impossible,...more
The passage of the Biologics Price Competition and Innovation Act (BPCIA) in 2010 paved the way for the introduction of biosimilars in the United States. Biosimilars are large-molecule drugs that are highly similar, but not...more