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Regulatory Affairs Professional || Regulatory Compliance || Regulatory Strategy || CAPA || Change control || Pre-clinical and Clinical Research || Actively seeking full time opportunities in Regulatory and Quality domain

📢Exciting News 📍 Today, Accord Biopharma, Inc. a subsidiary of Intas Pharmaceutical Ltd has gotten the acceptance of its #Biosimilar DMB-3115 which is proposed biosimilar to STELARA ® (ustekinumab) from #USFDA 📌Accord Biopharma, Inc. conducted multi-regional Phase-III clinical trail in patients with plaque psoriasis. The main focus of the study was the rate of change in the Psoriasis Area and Severity Index (PASI) to assess skin symptom improvement. 💊 STELARA®, a Janssen Biotech blockbuster, approved for psoriasis, psoriatic arthritis, Crohn's, and colitis. It raked in $13.9B in U.S. sales in 2022, ranking among top biologics. #Biosimilar #USFDA #ustekinumab #accordbiopharma #Intas https://lnkd.in/eQiVMPst

Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115

Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA® Biosimilar DMB-3115

prnewswire.com

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