Accord BioPharma Reports US FDA’s Acceptance of BLA for DMB-3115 (Biosimilar, Stelara)
Shorts:
- The US FDA has accepted the BLA for DMB-3115 based on the results from P-III multi-regional studies for treating plaque psoriasis having rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms as its 1EP. The results showed similar quality, safety and efficacy between DMB-3115 vs Stelara
- Accord BioPharma (subsidiary, Intas Pharmaceuticals) holds US commercialization rights to DMB-3115 which was jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma
- Additionally, the company has submitted 3 separate BLAs to the US FDA for its biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim
Ref: PRNewswire | Image: Accord BioPharma
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
