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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

    European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (25 May 2017)

    Welcome to our European Regulatory Roundup, a weekly overview of top EU regulatory news. Merck Accused of Blocking Remicade Biosimilars, Using Abusive Discount Scheme The UK’s competition watchdog has accused Merck of running an abusive discount scheme to defend Remicade against biosimilar competition. Merck has a chance to respond to the provisional decision before the watchdog rules whether it has violated competition law and faces a fine. Officials at the Co...
  • European Regulatory Roundup: Italy Fines Aspen $5.7M for Increasing Cancer Drug Prices by 1,500% (20 October 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Norwegian Government-Funded Study Supports Switching Patients to Remicade Biosimilar A trial funded by the Norwegian government has generated data to support switching from Johnson & Johnson’s Remicade to a biosimilar. Overall, participants with rheumatoid arthritis, Crohn’s disease and other conditions who switched to the biosimilar had comparable outcomes to patients ...
  • Regulatory NewsRegulatory News

    MHRA Raises Concerns Over Improper Biosimilar Marketing

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway. The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of...
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    Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds

    For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments. “The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countr...
  • Regulatory NewsRegulatory News

    FDA Briefing Documents Offer Support for Remicade Biosimilar

    The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing. The 73-page document offers new insight into what Celltrion submitted to support the licensure of its biosimilar, known as CT-P13, for Johnson and Johnson’s reference product, and FDA officials noted that the two products are “highly similar,” though th...