In the latest contest over biosimilars, AbbVie has filed a patent infringement lawsuit against Amgen, an erstwhile rival in the market for hard-to-make treatments for rheumatoid arthritis. And the move highlights a strategy designed to indefinitely delay the arrival of a lower-cost biosimilar indefinitely while the litigation plays out.
The lawsuit, which was filed last Thursday in federal court in Wilmington, Del., alleged that Amgen’s version of Humira violates 10 different patents. In its complaint, AbbVie asked the court to keep a biosimilar version from becoming available if the US Food and Drug Administration decides to approve the Amgen medication.
The lawsuit was largely expected, given the complex machinations of a federal law governing the entrance of biosimilars into the marketplace and subsequent court rulings. The Biologics Price Competition and Innovation Act, which became law as part of the Affordable Care Act, requires an elaborate procedure before a biosimilar manufacturer can proceed with plans to sell its medicine.