A US District Court judge stopped J&J’s attempt to stop Amgen’s Stelara biosimilar from entering the market. The judge cited a “failure to comply,” noting that the Pfizer’s lawyers submitted documents exceeding the courts page limits. In addition, the lawyers only asked to go over the limit seven minutes ahead of submission. Pfizer may file again with documents that match the court’s specifications.
According to Fraiser Kansteiner, “J&J sued Amgen back in November, alleging the latter company’s plan to sell its biosimilar infringes two existing Stelara patents related to the drug’s active ingredient, plus methods of treatment in ulcerative colitis. Amgen’s Stelara biosim has yet to win approval. J&J contends Amgen filed its biosimilar application with the FDA on or before Nov. 3, teeing up a potential decision date sometime in 2023’s second or third quarter.”
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(Source: Fierce Pharma, March 3rd, 2023)