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History Repeats: Will US Stelara Settlements Follow Humira’s Lead?

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Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab  the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.

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Dong-A ST Achieves Therapeutic Equivalence With Stelara Biosimilar

Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.

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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
    • Specialty Pharmaceuticals
  • Other Names / Subsidiaries
    • Chemo-Sero Therapeutic Research Institute of Japan
    • Meiji Holdings
    • Meiji Seika Kaisha
    • KM Biologics Co., Ltd.
    • Kaketsuken
    • Romeck Pharma, LLC
    • Meiji Pharma USA Inc.
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