Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India

Roche has sought a harmonized regulatory approach for approval of innovative medicines and formulations in India, after its request for a trial waiver for subcutaneous Herceptin was turned down by an expert panel.

BASEL, SWITZERLAND - APR 17: Roche headquarters on April 19, 2013 in Basel, Switzerland. Rocheis a Swiss global pharma company that operates worldwide producing pharmaceuticals and diagnostics.
HERCEPTIN SC DECLINED A TRIAL WAIVER IN INDIA

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from India

More from Asia