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BioWorld - Saturday, May 23, 2026

Biosimilar

Home » Topics » Drugs » Biosimilar
  • Patent wheels
    May 14, 2026
    By Mari Serebrov

    USPTO doubles down on inconsistencies in dual IPR-court action

    The U.S. Patent and Trademark Office (USPTO) is driving home its message that inter partes reviews (IPRs) are not to be used in conjunction with court action presenting “inconsistent positions” as a litigation strategy.
  • Three red darts on target
    April 28, 2026
    By Marian (YoonJee) Chu

    Sun Pharma to acquire Merck spinoff Organon for $11.75B

    Sun Pharmaceuticals Industries Ltd. will pay $11.75 billion cash to acquire Organon & Co. The transaction is expected to close in early 2027. The addition of Organon’s women’s health products, legacy drug brands and biosimilars are expected to boost Mumbai, India-based Sun’s global reach. The all-cash buy is also expected to relieve Jersey City, N.J.-based Organon of an $8.6 billion debt pile, accumulated after its debt-laden 2021 spinout from Merck & Co. Inc.
  • Capitol
    April 27, 2026
    By Mari Serebrov

    US legislative reforms needed to make biosimilars competitive

    Now that the FDA is on board with doing away with the U.S.’ unique two-tier biosimilar pathway, the biosimilar industry is urging Congress to pass the bipartisan Biosimilar Red Tape Elimination Act, which would recognize that biosimilars and interchangeables are one and the same.
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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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