Brief: Hungary's Richter announces positive results of its proposed biosimilar RoActemra

Richter Gedeon Vegyeszeti Gyar Nyrt

15/01/2025 07:06

Jan 15 (Reuters) - Richter Gedeon Vegyeszeti Gyar Nyrt
 GDRB.BU  said in a statement:
    * ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 1 AND PHASE
3
CLINICAL STUDIES FOR ITS PROPOSED BIOSIMILAR ROACTEMRA
(TOCILIZUMAB - RGB-19)
    * BOTH STUDIES MET THE ENDPOINTS DEMONSTRATING CLINICAL
SIMILARITY
BETWEEN RGB-19 AND THE REFERENCE BIOLOGIC
    * RGB-19 HAS BEEN DEVELOPED JOINTLY BY RICHTER AND MOCHIDA
PHARMACEUTICAL CO LTD
    * BOTH CLINICAL STUDIES WERE CONDUCTED IN JAPAN
    * RICHTER EXPECTS TO FILE FORE MARKETING AUTHORIZATION
APPLICATIONS FOR RGB-19 IN MAJOR EUROPEAN MARKETS IN THE COMING
MONTHS
    * MOCHIDA EXPECTS TO FILE FOR MARKETING AUTHORIZATION
APPLICATION
FOR RGB-19 IN JAPAN

Source text: [https://bse.hu/site/newkib/en/2025.01./Extraordinary_Information_129184342
]
Further company coverage:  GDRB.BU 

 (Reporting by Anita Komuves)
 ((KOMUVES.Anita@thomsonreuters.com;))