Roche Calls For Harmonized Regulation As Subcutaneous Herceptin Is Denied Trial Waiver In India
Executive Summary
Roche’s subcutaneous (SC) Herceptin (trastuzumab) has been declined a trial waiver in India, at least for now, stretching potential launch timelines for the product significantly. The company emphasizes that a harmonized regulatory approach could best serve patient interests for therapies like Herceptin that come with a ‘long history of proven efficacy’.
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