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FDA Accepts Accord BioPharma's BLA for Proposed Ustekinumab Biosimilar DMB-3115
January 4th 2024The BLA submission for DMB-3115 is rooted in phase III multi-regional clinical trials focusing on plaque psoriasis patients. The results demonstrated a high similarity between DMB-3115 and ustekinumab in terms of quality, safety, and efficacy.
CareFirst Files Lawsuit Against J&J Over Delay Tactics for Stelara Biosimilars
January 4th 2024While the first ustekinumab biosimilar, Wezlana, was approved in October 2023, a settlement with Johnson & Johnson (J&J) will keep it off the market until 2025, preventing competition, and causing purchasers to pay substantially more for the agent.