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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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Will GMP Lapses Stall Biocon-Mylan’s Biosimilars Build-Up?

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.

Will GMP Lapses Stall Biocon-Mylan’s Biosimilars Build-Up?

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.

Biosimilars For Avastin, Herceptin To Cap Off Busy July For ODAC

Pfizer's Mylotarg attempt to return to US market is first up for FDA's Oncologic Drugs Advisory Committee, followed by Novartis's CAR-T therapy. ODAC will then give half-day review to Amgen's and Mylan's biosimilars, suggesting FDA is increasingly comfortable with the product category.

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