Search Results for Zarxio

Showing 1 – 5

70 Groups Call on FDA to Revert Back to Meaningful Suffixes for Biosimilar Names By Zachary Brennan - Published 12 May 2016

The fight over how biosimilars should be named in the US isn’t over yet despite the US Food and Drug Administration’s (FDA) use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: biosimilar names, Zarxio, meaningful suffixes for biosimilars, FDA guidance

Sandoz Petitions Supreme Court to Rule on Biosimilars By Zachary Brennan - Published 17 February 2016

Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before bringing their product to market.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Compliance, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Supreme Court, SCOTUS, biosimilar lawsuit, biosimilar litigation, Sandoz, Amgen, Apotex, Zarxio

FDA's Woodcock to Senators: Need to First Get the Science Right on Biosimilars By Zachary Brennan - Published 17 September 2015

One of the most important parts of launching a robust US biosimilar market and setting up the regulations to support it is to make sure the scientific framework is "bulletproof," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators on Thursday.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, FDA, interchangeability, FDA guidance, Janet Woodcock, Zarxio

Zarxio, First Biosimilar Approved in the US, Added to FDA's New 'Purple Book' By Alexander Gaffney, RAC - Published 16 April 2015

Slowly but surely, the US Food and Drug Administration (FDA) is making quiet but substantial updates to its new "Purple Book"— a list meant to describe the degree to which a biosimilar drug is equivalent to the biologic product it references.

Categories: News, US, CBER, CDER, Biologics and biotechnology

Tags: Purple Book, Zarxio, Biosimilar, Interchangeable

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