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Medytox Files ITC Complaint Against Hugel to Block Import of Botox Follow-On

On March 30, 2022, Medytox filed a complaint with the ITC requesting that the ITC block imports of Hugel’s follow-on biologic Letybo® (LetibotulinumtoxinA) product.  The complaint alleges that Hugel expects to obtain approval and launch its product in the U.S. in 2022.  The complaint alleges that “Hugel misappropriated Medytox’s trade…

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Amgen v. Hospira Pegfilgrastim Case Stayed Pending Potential Summary Judgment Practice

On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim).  In the Order, the Court construed the term “between about 0.1 M…

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Biosimilar Manufacturing Update

On March 25, 2021, biosimilar manufacturer mAbxience announced that it is expanding its León, Spain manufacturing facility with a new 4,000 L Custom Single Run (“CSR”) bioreactor.  mAbxience claims its León plant is “the biggest biologic plant in Spain and the first in Europe with fully integrated single-use technology in…

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