Search Results for Follow-on Biologic

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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

New EMA Guideline Establishes Framework for Biosimilars, Use of International Comparator Studies By Alexander Gaffney, RF News Editor - Published 02 May 2013

Categories: EMA

Tags: Biosimilarity, Draft Guideline, Latest News, follow-on biologic, biologic, biosimilar, EU

FDA Releases Fourth Biosimilar Guidance Outlining New Types of Meetings By Alexander Gaffney, RF News Editor - Published 01 April 2013

Categories: Meetings, US, FDA, CBER, CDER

Tags: follow-on biologic, biosimilar, Biosimilars