Search Results for Celltrion

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Updated: FDA Form 483 for Celltrion Site Manufacturing Remicade Biosimilar By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US.

Categories: News, Asia, US, FDA, Biologics and biotechnology, Crisis management

Tags: Celltrion, Form 483, Pfizer, Inflectra

EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars By Zachary Brennan - Published 19 May 2017

The European Medicines Agency (EMA) met earlier this week and signed off on five new medicines, including one new advanced therapy, as well as four biosimilars and one generic drug.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: CHMP, Sanofi, Celltrion, XBiotech, Spherox

European Regulatory Roundup: Italy Fines Aspen $5.7M for Increasing Cancer Drug Prices by 1,500% (20 October 2016) By Nick Paul Taylor - Published 20 October 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Manufacturing, Quality

Tags: Remicade, Celltrion, Aspen, AIFA, NIBSC

Woodcock: FDA Needs More Funds for Biosimilar Review Program By Zachary Brennan - Published 04 February 2016

Shuttling back and forth between two different House committee hearings on Thursday, US Food and Drug Administration’s CDER Director Janet Woodcock made clear in a later hearing on biosimilars that the agency needs Congressional appropriations to properly run its biosimilar review program.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Due Diligence, Government affairs, Labeling, Quality

Tags: biosimilars, BPCIA, biologics, Remsima, Celltrion

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