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BioWorld - Friday, January 16, 2026

Biosimilar

Home » Topics » Drugs » Biosimilar
  • Ema icons
    Jan. 15, 2026
    By Nuala Moran

    EMA marks 2025 2nd busiest year, says pace will continue in 2026

    The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.
  • Gastrointestinal vector framework
    Dec. 30, 2025
    By Tamra Sami

    China approves Innovent’s ipilimumab for colon cancer

    China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer.
  • Gastrointestinal vector framework
    Dec. 29, 2025
    By Tamra Sami

    China approves Innovent’s ipilimumab for colon cancer

    China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer.
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Blog Posts

  • Aug. 11, 2016
    By Mari Serebrov

    Will biosimilar carve-outs put R&D for older MAbs on ice?

  • Sep. 29, 2014
    By Mari Serebrov

    Emerging biosimilar market knows no parallel

  • Feb. 19, 2014
    By Mari Serebrov

    Biosimilar regulation: 1984 v. 2014

  • Oct. 30, 2013
    By Lynn Yoffee

    An Asia Strategy is Not Optional

  • Oct. 1, 2013
    By Mari Serebrov

    It’s How You Look at the Vial

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Authors

  • Mari Serebrov
  • Michael Harris
  • Lynn Yoffee
  • Jihyun Kim
  • Sergio Held
  • Elise Mak
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