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  • Regulatory NewsRegulatory News

    Pfizer Not Planning US Launch of its Second Remicade Biosimilar Approved by FDA

    The US Food and Drug Administration (FDA) late Wednesday approved the ninth biosimilar in the US and the third for J&J’s Remicade (infliximab). But Pfizer said it will not launch Ixifi (infliximab-qbtx) in the US as the company already has another Remicade biosimilar on the market, known as Inflectra (infliximab-dyyb) (the third Remicade biosimilar is Merck and Samsung Bioepis’  Renflexis  (infliximab-abda)). Pfizer spokesman Thomas Biegi explained to Focu s that Ix...
  • Regulatory NewsRegulatory News

    Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars

    Pfizer on Wednesday filed a complaint in a US District Court in Pennsylvania alleging that Johnson & Johnson (J&J) is using "improper exclusionary tactics" to maintain dominance in the US market for its blockbuster Remicade (infliximab) despite recently introduced competition. First approved in 1998, J&J's tumor necrosis factor-inhibiting biologic is used to treat a range of immune-mediated diseases in almost 500,000 Americans, including for Crohn's disease, ulcerat...
  • Regulatory NewsRegulatory News

    Updated: FDA Form 483 for Celltrion Site Manufacturing Remicade Biosimilar

    The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US, though Pfizer says the limited uptake has more to do with Johnson and Johnson's exclusionary contracts. The Form 483 for the Incheon, Korea-base...