EMA Accepts MAA for DMB-3115, a Stelara Biosimilar by Dong-A ST

EMA Accepts Marketing Authorization Application for DMB-3115, a Stelara Biosimilar by Dong-A ST

 

Confirmation of Therapeutic Equivalence and Safety between DMB-3115 and Stelara in Global Phase III Trial

 

SEOUL, South Korea--(BUSINESS WIRE)-- On July 14, Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced that the European Medicine Agency (EMA) has accepted the Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).

 

The MAA was submitted to EMA by Accord, a wholly owned subsidiary of Intas Pharmaceuticals Ltd, on June 23rd. The acceptance of the MAA submission by EMA took place on July 14th in CET.

'Pharmacology > BS' 카테고리의 다른 글

Adcentrx Therapeutics Announces FDA Clearance of Investigational New Drug Application for ADRX-0706, a Novel ADC Targeting Nectin-4 for the Treatment of Advanced Solid Tumors  (0)	2023.07.18
Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma  (0)	2023.07.18
"ALZHEIMER'S ASSOCIATION STATEMENT ON DONANEMAB PHASE 3 DATA REPORTED AT AAIC 2023"  (0)	2023.07.18
Clearside Biomedical Announces Enrollment of Multiple Participants in its ODYSSEY Phase 2b Clinical Trial of CLS-AX (axitinib injectable suspension) in Wet AMD  (0)	2023.07.18
Acumen Pharmaceuticals to Hold Conference Call to Discuss Positive Topline Results from First-in-Human Phase 1 Study of ACU193 for Early Alzheimer’s Disease  (0)	2023.07.18