EMA Accepts Application for Trastuzumab Biosimilar

May 29, 2019 – The European Medicines Agency (EMA) has validated and accepted a marketing authorization application for the trastuzumab biosimilar HD201, according to the developer Prestige BioPharma. The application is based on findings from a phase I study and the phase III TROIKA trial (NCT03013504), both of which demonstrated that HD201 is comparable to reference trastuzumab in terms of clinical response, pharmacokinetics (PK), and safety. “We are very … (leggi tutto)