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Drug Review Profiles: Behind The Scenes At US FDA

Executive Summary

A year in our long-running series of deep dives into FDA review documents.

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Genentech's Ocrevus Manufacturing Process Still A Work In Progress

Genentech overcame objections from US FDA quality reviewers to win approval of Ocrevus for multiple sclerosis by adding release and stability testing and committing to resolving process control issues, while suspending plans to accelerate post-approval manufacturing changes.

Multiple Sclerosis Subtype 'Relatedness' Drove Debate On Ocrevus Approval

Genentech's Ocrevus BLA set off internal US FDA dispute about relationship between different subgroups of disease: Can strong evidence in one form (relapsing MS) confirm a weak study in another (primary progressive MS)? Our Drug Review Profile looks at how FDA rationalized approval of Ocrevus for PPMS.

Biosimilar Sponsors Took Delivery Device Shortcuts For Erelzi, Amjevita

Sandoz’s and Amgen’s biosimilars employ autoinjectors that are currently used with the sponsors’ novel biologic products, allowing them to avoid additional human factors study testing of the delivery devices.

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