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« USPTO Proposes More Rules for Implementing AIA Provisions | Main | USPTO to Hold Hearing on Genetic Diagnostic Testing »

February 14, 2012

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Listed below are links to weblogs that reference More on FDA Draft Guidelines for "Follow-on" Biologic Drug Approval Pathway:

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"The draft guidance also advocates a "risk-based" approach, which will permit variances in biologic drug properties and characteristics (including primary amino acid sequence) if justified by the biosimilar applicant." Changes in the primary amino acid sequence are VERY concerning for any of us who want to rely on our patent during the PTE period. Not good at all.

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