Search Results for biosimilar labels

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Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels By Zachary Brennan - Published 03 August 2016

Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label.

Categories: News, US, FDA, Biologics and biotechnology, Labeling

Tags: Novartis, Amgen, Pfizer, Sandoz, AbbVie, Takeda, Boehringer, biosimilar, labeling guidance, biosimilar labels, interchangeability

FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling By Zachary Brennan - Published 31 March 2016

The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must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

PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition By Zachary Brennan - Published 21 January 2016

The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Submission and registration

Tags: biosimilar labels, US biosimilar market, Omnitrope, PhRMA, BIO