Advances On the Biosimilar Litigation Battlefield
A look at the evolution of litigation, from Amgen's 'bold' at-risk launch of Herceptin and Avastin biosimilars to the jump in settlements, new battles over manufacturing information and an expected petition to the Supreme Court.
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AbbVie claims a former employee took Humira manufacturing process know-how to Alvotech. Settlement is likely as Alvotech does not want to delay development of its biosimilar and AbbVie doses not want to disclose its trade secrets in court.
Emergence of the inter partes review process dramatically changed the patent dispute arena. The decade also brought biosimilar litigation, generic price-fixing complaints, opioid lawsuits and new government investigations and antitrust actions.
The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.