On May 19, 2022, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued opinions recommending the refusal of marketing authorization for Prestige BioPharma Ltd.’s HD201, TUZNUE and...more
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