More Herceptin Biosimilars Move In, But Roche Thinks It Can Stand Its Ground
Executive Summary
Two biosimilar versions of Roche's blockbuster cancer therapy Herceptin reported positive Phase III bioequivalence data at ASCO – setting up for regulatory approvals in Europe, the US and Japan soon.
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Compliance deviations flagged by French regulator ANSM at Biocon’s Indian site have raised questions around commercialization timelines in the EU for the firm and partner Mylan’s biosimilars, including trastuzumab. The news comes ahead of an FDA advisory panel review later this week for the product. Biocon, though, appears confident of setting compliance woes right quickly.
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