If Roche was hoping to shake up the Indian trastuzumab market with its subcutaneous (SC) formulation of Herceptin, a more convenient and cost-effective preparation than the original intravenous (IV) form, then it may have to wait, at least for now.
A subject expert committee (SEC), which advises the Indian regulator on trial-related permissions, has turned down the Swiss multinational’s request for a trial waiver for Herceptin SC, that was backed by data generated in other countries
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