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Thu, May 22, 2025

Generic

Home » Topics » Drugs » Generic
  • Approval stamp blue
    May 6, 2025
    By Marian (YoonJee) Chu

    South Korea approves record number of biosimilars in 2024

    South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
  • Approval stamp blue
    April 30, 2025
    By Marian (YoonJee) Chu

    South Korea approves record number of biosimilars in 2024

    South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.
  • Eu pharma illustration
    April 9, 2025
    By Mari Serebrov

    Many US tariffs paused, pharma warned, EU put on notice

    The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.
Read More

Blog Posts

  • Aug. 11, 2016
    By Mari Serebrov

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

  • Feb. 27, 2013
    By Mari Serebrov

    Omontys Recall Rings Alarm Over Biosimilars

  • Jan. 29, 2013
    By Mari Serebrov

    Don’t Call Them Generics!

Read More

Authors

  • Mari Serebrov
  • Lee Landenberger
  • Richard Staines
  • Doris Yu
  • Jennifer Boggs
  • Marian (YoonJee) Chu
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