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Halozyme Therapeutics, Inc. Message Board

  • fezziwig2008 fezziwig2008 Feb 4, 2013 11:04 PM Flag

    Herceptin- SC Approval in 2Q13- As per Julian Cole - Head of Medical Affairs (Oncology) at Roche- article

    "Roche is waiting to receive a license indication from the European Medicines Agency (EMA) for Herceptin subcutaneous, and we would expect to have the license sometime in the first half 2013."
    Julian Cole, head of medical affairs (oncology) at Roche Products

    Breaking barriers – the potential of subcutaneous drug delivery
    13 December 2012

    EE: How soon can we expect Herceptin and MabThera to be able to be administered by subcutaneous injection to the wider patient population?
    JC: Roche is waiting to receive a license indication from the European Medicines Agency (EMA) for Herceptin subcutaneous, and we would expect to have the license sometime in the first half 2013.
    "A subcutaneous injection also does not require venous access, which can be less invasive and less painful for the patient."
    NICE (England and Wales) is producing an evidence summary for Herceptin subcutaneous and its publication is planned for Jan 2013. SMC (Scotland) will conduct a health technology appraisal in due course.
    When it comes to MabThera, Roche is planning to submit for an updated license for MabThera with the EMA to allow all eligible NHL patients to receive MabThera via subcutaneous injection.
    We anticipate this process will be concluded during the second half of 2013.

    With a switch from IV to subcutaneous it is expected that healthcare professional (HCP) time, patient time occupying an IV chair and medical supplies usage would also be reduced, the savings of which could be reinvested in other patient care activities, or increase the number of patients being treated at the care unit.

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