Search Results for Amgen

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FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote By Michael Mezher - Published 25 May 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications.

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

Tags: Epoetin alfa, Epogen, Hospira, Pfizer, Amgen, Biosimilar

FDA Science Board Weighs Plan for 'Cures' Funds By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: FDA science board, Celgene, GSK, Amgen, 21st Century Cures

US Supreme Court to Consider Biosimilar Patent Process Next Week By Zachary Brennan - Published 20 April 2017

The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Ethics, Government affairs

Tags: biosimilars, Amgen, Sandoz, patents

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

Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar By Zachary Brennan - Published 20 February 2017

Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Regulatory intelligence, Submission and registration

Tags: Genentech, Roche, Avastin, Amgen, biosimilars

Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics By Zachary Brennan - Published 20 February 2017

In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted.

Categories: News, US, Biologics and biotechnology, Government affairs, Research and development, Submission and registration

Tags: biosimilars, GPhA, AAM, Biosimilars Council, Amgen, Sandoz

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 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

Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels By Zachary Brennan - Published 03 August 2016

Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label.

Categories: News, US, FDA, Biologics and biotechnology, Labeling

Tags: Novartis, Amgen, Pfizer, Sandoz, AbbVie, Takeda, Boehringer, biosimilar, labeling guidance, biosimilar labels, interchangeability

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

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

Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory By Zachary Brennan - Published 05 July 2016

The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Research and development

Tags: biosimilar patent dance, Apotex, Amgen, Federal Circuit

TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators By Zachary Brennan - Published 29 June 2016

The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients.

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Clinical, Crisis management, Drugs

Tags: TransCelerate, Lilly, Pfizer, AstraZeneca, Amgen

Sandoz Petitions Supreme Court to Rule on Biosimilars By Zachary Brennan - Published 17 February 2016

Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before bringing their product to market.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Compliance, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Supreme Court, SCOTUS, biosimilar lawsuit, biosimilar litigation, Sandoz, Amgen, Apotex, Zarxio

European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016) By Nick Paul Taylor - Published 11 February 2016

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

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement, Veterinary products

Tags: NICE, Xarelto, Paluent, Sanofi, Amgen, ENVI

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

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

GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5 By Zachary Brennan - Published 07 January 2016

The Generic Pharmaceutical Association’s Biosimilars Council is taking issue with a recent court decision that could effectively delay the launch of biosimilars in the US by an additional six months, according to an amicus brief.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, GPhA, Apotex, Amgen

GMP Deficiencies in Spotlight in Warning Letters to Amgen, Baxter By Alexander Gaffney, RAC - Published 11 February 2014

Categories: US, FDA

Tags: 21 CFR 820, Baxter, Amgen, warning letter, Latest News, GMP

Amgen's Aranesp Target of OPDP Letter, Agency's Seventh in as Many Weeks By Alexander Gaffney, RF News Editor - Published 22 November 2013

Categories: US, FDA

Tags: OPDP, Aranesp, Untitled Letter, Amgen, Latest News

UK: NICE Revises Guidance on Amgen's Denosumab By Louise Zornoza, RegLink - Published 13 June 2012

Categories: Regulatory Update, NICE

Tags: Reverse, Denosumab, Amgen, Recommendation, UK, draft guidance, cancer

Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit By Alexander Gaffney - Published 12 June 2012

Tags: Aranesp, Epogen, Case, Amgen, Class Action, Securities, Lawsuit, Court, SCOTUS, Latest News

House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations By Alexander Gaffney - Published 08 May 2012

Tags: Negotiating, Amgen, Abbott, AstraZeneca, Pfizer, Merck, E&C, Energy and Commerce Committee, PhRMA, House, negotiation, Latest News, Obama, PPACA, information

Biosimilars Guidelines Attract Attention, Criticism By Alexander Gaffney - Published 26 April 2012

Categories: FDA

Tags: Amgen, Comments, BIO, Latest News, BPCI, testing, biosimilar, draft guidance, guidance, Biosimilars