Search Results for Humira

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Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B By Zachary Brennan - Published 02 October 2017

Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018.

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

Tags: AbbVie, Amgen, Humira, biosimilar, CMS

FDA Approves 6th Biosimilar in US, Second for Humira By Zachary Brennan - Published 28 August 2017

The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab).

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

Tags: biosimilars US approval, Boheringer Ingelheim, Cyltezo, Humira

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

EMA Recommends Two Amgen Humira Biosimilars By Zachary Brennan - Published 27 January 2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended eight medicines for approval, including two Amgen biosimilars for AbbVie’s blockbuster Humira (adalimumab).

Categories: News, Asia, Europe, US, EC, EMA, FDA, Biologics and biotechnology

Tags: Humira, Amgen, AbbVie, blockbuster drugs

FDA Approves First Humira Biosimilar By Michael Mezher - Published 23 September 2016

The US Food and Drug Administration (FDA) on Friday announced it had approved Amgen's Amjevita (adalimumab-atto), the first biosimilar version of AbbVie's best-selling biologic Humira (adalimumab).

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

Tags: Humira, Amjevita, Biosimilar, adalimumab, adalimumab-atto

Ulcerative Colitis Drugs: FDA Offers Draft Guidance on Clinical Development By Zachary Brennan - Published 08 August 2016

Pharmaceutical companies looking to understand FDA’s current thinking on efficacy endpoints for clinical trials to develop new ulcerative colitis (UC) treatments will be interested in new draft guidance released Friday.

Categories: News, US, FDA, Drugs, Due Diligence, Government affairs, Research and development

Tags: ulcerative colitis, Humira, efficacy endpoints, primary endpoints, patient-reported outcomes

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 Panel Unanimously Backs Amgen’s Humira Biosimilar By Zachary Brennan - Published 12 July 2016

The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee on Tuesday voted unanimously to support Amgen’s biosimilar for AbbVie’s blockbuster biologic Humira (adalimumab).

Categories: News, US, FDA, Biologics and biotechnology

Tags: AAC, advisory committee vote, Humira

FDA Staff Back Biosimilar to Compete With Blockbuster Humira By Zachary Brennan - Published 08 July 2016

Competition for one of the world’s top-selling biologics – AbbVie’s Humira (adalimumab) – is likely to come in the near future, as staff at the US Food and Drug Administration (FDA) said Friday that Amgen’s biosimilar has “no clinically meaningful differences” with the US-licensed Humira, in terms of safety, purity and potency.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Preclinical

Tags: Humira, AbbVie, Amgen, biosimilar

NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta By Michael Mezher - Published 22 June 2016

The UK's National Institute for Health and Care Excellence (NICE) on Wednesday issued recommendations for six drugs after agreeing to discounts with their respective manufacturers, clearing the drugs for use by the country's National Health Service (NHS).

Categories: News, Europe, NICE, Biologics and biotechnology, Drugs, Reimbursement, Submission and registration

Tags: Zykadia, Mekinist, Praluent, Repatha, Humira, Benlysta, NICE, NHS

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

EU Ombudsman Calls on EMA to Release Redacted Humira Study Data By Michael Mezher - Published 10 June 2016

The EU Ombudsman is calling for the European Medicines Agency (EMA) to release more information from three clinical trials for one of the most commercially successful drugs of all time, AbbVie's arthritis drug Humira (adalimumab), and says EMA should also make changes to how it handles disclosing information in the future.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs

Tags: Transparency, Humira

Facing High-Profile Criticism, EMA Defends Data Transparency Policy By Michael Mezher - Published 13 February 2015

Regulators are often faced with balancing commercially confidential information with the public’s right to access documents.   In a letter from European Ombudsman Emily O’Reilly late last year, the European Medicines Agency (EMA) was called out over how it handled that balance when responding to an "access to documents" request in 2013. Now the agency has responded to that letter, issuing a response to the ombudsman that both defends and apologizes for its handling of clinical study report (CSR) data.

Categories: News, Europe, EMA, Government affairs

Tags: European Ombudsman, Clinical Study Reports, Access to Documents, Transparency, Humira