• Mashup Score: 1
    Market gears up for biosimilar boom in 2023 as Humira exclusivity draws to a close - 3 year(s) ago

    On May 11, Icelandic-based drug developer Alvotech filed a lawsuit against AbbVie seeking to undo what it alleges is a “minefield” of “invalid” patents surrounding what is arguably the pharma giant’s most prized possession: Humira.Just 2 weeks prior, AbbVie had filed a lawsuit of its own against Alvotech — currently seeking FDA approval for its Humira

    Source: www.healio.com
    Categories: Latest Headlines, Rheumatology
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      HealioRheum

      U.S. #DrugMarket prepares for a #Humira #biosimilar boom in 2023, as market exclusivity on the long-reigning #blockbuster TNF inhibitor comes to an end - what should patients and providers expect in the meantime? https://t.co/4eCtMzlV0N

  • Mashup Score: 7
    FDA rejects filgotinib for moderate to severe active RA due to testicular toxicity - 4 year(s) ago

    Gilead announced the FDA has issued a complete response letter regarding the new drug application for filgotinib as a treatment for moderately to severely active rheumatoid arthritis.The FDA issues a complete response letter to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form for one or more reasons. In this case, the

    Source: www.healio.com
    Categories: Latest Headlines, Rheumatology
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      The #FDA has rejected Gilead’s potential #blockbuster #filgotinib for the treatment of moderate to severe #rheumatoidarthritis due to #testicular toxicity concerns https://t.co/nEKTepqSEG