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，纽交所:RDY，NSEIFSC:DRREDDY，及其子公司统称为“Dr. Reddy's”）今天宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已采纳了一项积极意见，推荐其在欧洲市场推出所建议的生物类似物Rituximab候选品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此前已收到其位于印度海得拉巴的Rituximab药品物质和药品生产设施的欧洲药品管理局认证。作为既定的批准流程的一部分，CHMP的积极意见现在将由欧洲委员会（EC）审查，随后将就在欧洲联盟（EU）成员国，以及挪威、冰岛和列支敦士登的欧洲经济区（EEA）成员国授权上市做出决定。将分别根据国际认可程序（IRP）的依赖路线进行提交给英国药品和保健品监管局(MHRA)的上市授权申请(MAA)。