Search Results for interchangeability

Showing 1 – 10

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance By Michael Mezher - Published 17 January 2017

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Postmarket surveillance, Preclinical, Submission and registration

Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study

CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming By Zachary Brennan - Published 11 January 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: interchangeability, FDA guidance, guidance agenda, CDER guidance

FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance By Zachary Brennan - Published 22 September 2016

Although the Food and Drug Administration (FDA) has continued to say that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017.

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

Tags: biosimilar, interchangeability, BsUFA

Biosimilar Interchangeability: ‘Careful What You Wish For’ By Zachary Brennan - Published 08 September 2016

As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts are saying the designation might not actually be that important for the biosimilar market as a whole.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: interchangeability, biosimilars, biologics and biosimilars, Momenta Pharmaceuticals, Pfenex, Sandoz, GPhA

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

Updated: Biosimilars in the US: Panel Discusses Tricky Balance of Building the Market With Necessary Precautions By Zachary Brennan - Published 20 June 2016

Biosimilar experts, including the US Food and Drug Administration's (FDA) Dr. Leah Christl and biosimilar developer Coherus Biosciences' chief medical officer Dr. Barbara Finck, sat down on Monday at an Alliance for Health Reform event to discuss the challenges the US faces in developing a robust biosimilars market and also ways the US can avoid fear mongering and increase uptake.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Government affairs, Quality, Research and development

Tags: biosimilars, interchangeability, BPCIA

FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say By Zachary Brennan - Published 12 January 2016

The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. 

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Manufacturing, Preclinical

Tags: biosimilars, interchangeability, 351(k) application, Amgen, Sandoz, biosimilar substitution

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

In Major Move on Biosimilar Interchangeability, FDA Establishes New 'Purple Book' By Alexander Gaffney, RAC - Published 09 September 2014

In a landmark move, the US Food and Drug Administration (FDA) has published its first-ever edition of the "Purple Book," a new list of licensed biological products and interchangeable biosimilars that is meant to be the biological equivalent of the pharmaceutical "Orange Book."

Categories: News, US, CBER, CDER, Biologics and biotechnology, Labeling, Regulatory strategy

Tags: Purple Book, Orange Book, Biosimilarity, Biosimilar, Biosimilars, Interchangeability, Biosimilar Interchangeability

Biosimilar Interchangeability Problems Pose Complex Challenge for Regulators By Alexander Gaffney - Published 28 September 2012

Categories: Under RAPS

Tags: Interchangeability, BPCI Act, Complexity, Problems, reference, PPACA, biosimilar, Biologics