Search Results for biosimilar approval

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FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling By Zachary Brennan - Published 31 March 2016

The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product.

Categories: News, US, FDA, Biologics and biotechnology, Labeling, Project management, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Research and development

Tags: biosimilar labels, biosimilar approval, reference product labeling

FDA Approves US' First Biosimilar Product, but Regulatory Questions Remain By Alexander Gaffney, RAC - Published 06 March 2015

The US Food and Drug Administration (FDA) has announced the landmark approval of the US' first biosimilar product, Sandoz' Zarxio (filgrastim-sndz), a drug biologically similar to Amgen's Neupogen.

Categories: News, US, CDER, Biologics and biotechnology, Labeling, Submission and registration

Tags: Biosimilar, Biosimilar Approval, FDA Biosimilar, Neuopogen Biosimilar, Filgrastrim-sndz, Sandoz, Zarxio