Search Results for 351(k)

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FDA’s Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years By Zachary Brennan - Published 14 March 2016

A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies continue to seek more meetings with FDA on specific issues and targeted advice.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Clinical, Compliance, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, FDA work on biosimilars, 351(k), BLA, FDA FTEs

FDA Briefing Documents Offer Support for Remicade Biosimilar By Zachary Brennan - Published 05 February 2016

The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing.

Categories: News, US, EMA, FDA, Biologics and biotechnology, Clinical, Due Diligence, Government affairs, Research and development

Tags: Remicade, biosimilar, 351(k) application, clinical trials to support biosimilars

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 Workload, Spending on Biosimilars Program Picks Up in 2015, Report Says By Zachary Brennan - Published 23 September 2015

In the first two and a half years of the US Food and Drug Administration (FDA)’s biosimilars review program, the agency is only recently starting to ramp up spending and manpower, according to an interim report from Eastern Research Group (ERG) released Wednesday.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs, Project management, Research and development

Tags: biosimilars, FDA, ERG, BLAs, 351(k)

FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody By Alexander Gaffney, RAC - Published 11 August 2014

South Korean biopharmaceutical manufacturer Celltrion has announced that it has filed an application for approval with the US Food and Drug Administration (FDA) for Remsima, its biosimilar version of Jannsen's Remicade (infliximab).

Categories: News, US, CDER, Biologics and biotechnology, Prescription drugs, Submission and registration

Tags: Biosimilar, Biosimilarity, Remsima, Celltrion, 351(k), Monoclonal Antibody

Sandoz First Company to File for Biosimilar Approval in US Under New Pathway By Alexander Gaffney, RAC - Published 24 July 2014

Biopharmaceutical company Sandoz, a Novartis subsidiary, has announced that it has filed the first-ever biosimilar application in the US with the Food and Drug Administration (FDA) using its 351(k) pathway.

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

Tags: Biosimilar, Biosimilarity, Follow-on Biologic, Sandoz, 351(k), First Biosimilar Filing in US

FDA Looks to Close Loophole That Could Delay Approval of Biosimilars By Alexander Gaffney, RAC - Published 10 March 2014

Categories: US, FDA

Tags: 351(k), 505(q), FDASIA, Citizen Petition, Latest News, FDAAA, biosimilar, FD&C Act