Dr. Reddy's Receives Positive CHMP Opinion From EMA For Its Proposed Rituximab Biosimilar Candidate DRL_RI
Dr. Reddy's Receives Positive CHMP Opinion From EMA For Its Proposed Rituximab Biosimilar Candidate DRL_RI
Dr. Reddy's Laboratories Ltd. ((BSE: 500124, NSE: DRREDDY, NYSE:RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's")), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI) in European markets.
印度Dr. Reddy's Laboratories Ltd.（BSE:500124，NSE:DRREDDY，紐交所:RDY，NSEIFSC:DRREDDY，及其子公司統稱爲“Dr. Reddy's”）今天宣佈，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）已採納了一項積極意見，推薦其在歐洲市場推出所建議的生物類似物Rituximab候選品DRL_RI（ITUXREDI）。
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad, India. As part of the established approval process, the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Union (EU) member countries, and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure (IRP).
Dr. Reddy's此前已收到其位於印度海得拉巴的Rituximab藥品物質和藥品生產設施的歐洲藥品管理局認證。作爲既定的批准流程的一部分，CHMP的積極意見現在將由歐洲委員會（EC）審查，隨後將就在歐洲聯盟（EU）成員國，以及挪威、冰島和列支敦士登的歐洲經濟區（EEA）成員國授權上市做出決定。將分別根據國際認可程序（IRP）的依賴路線進行提交給英國藥品和保健品監管局(MHRA)的上市授權申請(MAA)。
譯文內容由第三人軟體翻譯。