Search Results for Enbrel

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Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars By Zachary Brennan - Published 24 March 2017

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel

FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel By Zachary Brennan - Published 30 August 2016

The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be known as Erelzi (etanercept-szzs) for all indications included in the reference product’s label.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Due Diligence

Tags: biosimilar, Enbrel, Amgen, Novartis, Sandoz

Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz’s Enbrel Biosimilar By Zachary Brennan - Published 13 July 2016

For a second straight day, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has unanimously pushed for the approval of a new biosimilar, this time for Sandoz’s biosimilar for Amgen’s Enbrel (etanercept).

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

Tags: Sandoz, Novartis, Enbrel, Humira, biosimilars

FDA Staff: Sandoz’s Enbrel Biosimilar is ‘Highly Similar’ to Amgen's Blockbuster By Zachary Brennan - Published 11 July 2016

Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.”

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Submission and registration

Tags: biosimilar, Enbrel, Amgen, Sandoz, Novartis

Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds By Zachary Brennan - Published 20 June 2016

For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Due Diligence, Government affairs, Postmarket surveillance, Quality, Research and development

Tags: biosimilars, EU uptake of biosimilar medicinal products, IMS Health, EPO, Anti-TNF, Humira, Enbrel, Remicade

European Commission Clears First Enbrel Biosimilar Ahead of US By Zachary Brennan - Published 18 January 2016

The European Commission over the weekend signed off on the first biosimilar for Amgen’s blockbuster rheumatoid arthritis treatment Enbrel, a version of which is also making its way through a separate review by the US Food and Drug Administration (FDA).

Categories: News, Asia, Europe, US, EC, EMA, FDA, MFDS, Clinical, Due Diligence, Submission and registration

Tags: Enbrel, anti-TNF, MFDS, Amgen patents