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Kirin-Amgen Joint Venture To Become Wholly-Owned Subsidiary Of Amgen
$780 Million Payment to be Funded From Joint Venture's Existing Cash Holdings Kyowa Hakko Kirin to Continue as Licensee in Asia THOUSAND OAKS, Calif., Oct. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that Amgen and Kirin Holdings (Kirin) have agreed that Kirin-Amgen, a joint venture between the two companies, will redeem Kirin's shares in the joint venture and, as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen. Kirin-Amgen was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of EPOGEN® (epoetin alfa). Over time, the sco...
Source: Amgen News Release - October 31, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Are Biobetters Better?
Biosimilars and biobetters are both variants of a biologic drug, however, while biosimilars are close copies of the originator, biobetters have been improved, for example, in terms of efficacy, safety, tolerability or dosing regimen.Regulators consider biobetters as new products and so afford them the same patent protection as any originator, however, this means they require the same clinical and non-clinical data packages. Conversely, a reduced clinical data package is an attractive element for the development of biosimilars.Given the cost of development and the time pressure to bring a biobetter to market before biosimil...
Source: EyeForPharma - July 3, 2017 Category: Pharmaceuticals Authors: James Wright Source Type: news

Zarxio (Filgrastim-sndz Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 2, 2017 Category: Drugs & Pharmacology Source Type: news

Granix (Tbo-filgrastim Injection, for Subcutaneous Use) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 16, 2017 Category: Drugs & Pharmacology Source Type: news

Neupogen® (Filgrastim): General Information for Clinicians
Centers for Disease Control and Prevention, National Center for Environmental Health. 12/10/2015This resource provides information about Neupogen (Filgrastim), which was approved in March 2015 by the U.S. Food and Drug Administration (FDA) to treat people who have received high doses of radiation. Neupogen is a drug that has been used successfully for cancer patients to produce more white blood cells. The fact sheet discusses who can take Neupogen, how it is given, and its side effects. (Text) (Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - April 28, 2016 Category: Global & Universal Authors: The U.S. National Library of Medicine Source Type: news

Zarxio (Filgrastim-sndz Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 16, 2016 Category: Drugs & Pharmacology Source Type: news

What is the Difference Between Neulasta and...
Neutropenia during chemotherapy is treated with Neulasta or Neupogen. What's the difference, why is each chosen and what are the costs? (Source: About.com Breast Cancer)
Source: About.com Breast Cancer - March 16, 2016 Category: Cancer & Oncology Authors: breastcancer.guide at about.com Tags: health Source Type: news

NLM’s Radiation Emergency Medical Management (REMM) Site Redesigned
The National Library of Medicine’s Radiation Emergency Medical Management (REMM) site has been redesigned.  REMM now includes a more modern banner, a refreshed color palette and font style, and a new navigation system. There are six content groups and an easy-to-use navigational menu on the home page with sections for: Interactive Clinical Tools, Diagnosis and Treatment, Reference and Data, Overview of REMM, and Links to downloading the REMM app for various mobile devices Significant content updates have been added including: New references and on most of the Emergencies Incidents pages New references in the...
Source: Dragonfly - October 9, 2015 Category: Databases & Libraries Authors: Emily Glenn Tags: Emergency Preparedness News from NLM Technology Source Type: news

Sustained Rigors and Fever in Filgrastim HypersensitivitySustained Rigors and Fever in Filgrastim Hypersensitivity
Learn from this case study of a 36-year-old man who presented to an emergency room with fever, fatigue, and severe rectal pain. Oncology Nursing Forum (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 28, 2015 Category: Consumer Health News Tags: Nursing Journal Article Source Type: news

Novartis Neupogen Biosimilar: On Sale Now
Novartis' Zarxio -- the first U.S. biosimilar drug -- is on sale for 15% less than the original drug, Amgen's blockbuster, Neupogen. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - September 3, 2015 Category: Pharmaceuticals Source Type: news

Sandoz launches Zarxio (TM) (filgrastim-sndz), the first biosimilar in the United States
Launch follows March 6, 2015 FDA approval. Sandoz One SourceTM offers patient support services (Source: Pharmacy Europe)
Source: Pharmacy Europe - September 3, 2015 Category: Drugs & Pharmacology Authors: Annabel De Coster Tags: *** Editor's Pick Biosimilars Clinical trials Practical therapeutics Oncology fda approval filgrastim-sndz Latest News zarxio Source Type: news

Novartis Closer to Selling Copy of Amgen's Neupogen
A federal appeals court in Washington denied Amgen Inc.’s request for a temporary injunction to block Novartis AG from selling a copycat version of the blockbuster drug Neupogen in the U.S. (Source: WSJ.com: Health)
Source: WSJ.com: Health - September 2, 2015 Category: Pharmaceuticals Tags: PAID Source Type: news

Neupogen (Filgrastim Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 14, 2015 Category: Drugs & Pharmacology Source Type: news

Novartis's Sandoz cleared to launch generic version of Amgen’s Neupogen
Novartis's subsidiary Sandoz has been cleared to launch its biosimilar Zarxio (filgrastim) in September, after the US Court of Appeals for the Federal Circuit declined Amgen's claims. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - July 21, 2015 Category: Pharmaceuticals Source Type: news

Novartis Blocked From Selling Neupogen Copycat Until Sept. 2Novartis Blocked From Selling Neupogen Copycat Until Sept. 2
Novartis AG unit Sandoz must wait until Sept. 2 to sell Zarxio (filgrastim-sndz), the first biosimilar drug to be approved in the United States and a copycat version of Amgen Inc's $1.2 billion-a-year anti-infection drug Neupogen (filgrastim), a U.S. appeals court said on Tuesday. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 21, 2015 Category: Consumer Health News Tags: Infectious Diseases News Source Type: news

Drugmaker Novartis blocked from selling Neupogen copycat until Sept 2
NEW YORK (Reuters) - Novartis AG must wait until Sept. 2 to sell the first biosimilar drug to be approved in the United States, a copycat version of Amgen Inc's $1.2 billion-a-year Neupogen, a U.S. appeals court said on Tuesday. (Source: Reuters: Health)
Source: Reuters: Health - July 21, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Novartis Keeps Fighting for Neupogen Biosimilar
Novartis' Sandoz unit asked an appeals court to lift a preliminary injunction barring it from selling its biosimilar Zarxio, a cheaper version of Amgen's cancer blockbuster. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 4, 2015 Category: Pharmaceuticals Source Type: news

Novartis tries to get U.S. ban lifted on sale of Neupogen copycat
WASHINGTON (Reuters) - Novartis AG unit Sandoz asked a U.S. appeals court on Wednesday to lift a preliminary injunction barring it from selling its biosimilar Zarxio, a cheaper version of a drug that fends off infections in cancer patients. (Source: Reuters: Health)
Source: Reuters: Health - June 3, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Biosimilar Filgrastim vs Lenograstim in Autologous HSCTBiosimilar Filgrastim vs Lenograstim in Autologous HSCT
Find out how these biosimilars stack up for autologous HSCT in patients with hematological malignancies. Therapeutic Advances in Hematology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 2, 2015 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news

New research leads to FDA approval of first drug to treat radiation sickness
New research has led to FDA approval of the use of a drug to treat the effects of radiation exposure following a nuclear incident. The drug, Neupogen, is the first ever approved for the treatment of acute radiation injury. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 22, 2015 Category: Science Source Type: news

New research leads to FDA approval of first drug to treat radiation sickness
(University of Maryland School of Medicine) New research has led the FDA to approve use of a drug to treat the effects of radiation exposure following a nuclear incident. The drug, Neupogen, is the first ever approved for the treatment of acute radiation injury. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 22, 2015 Category: Global & Universal Source Type: news

Novartis 'biosimilar' drug blocked by U.S. appeals court
(Reuters) - A U.S. appeals court has blocked the sale of Novartis AG's recently approved "biosimilar" form of Neupogen, the blockbuster Amgen Inc drug used to prevent infections in cancer patients. (Source: Reuters: Health)
Source: Reuters: Health - May 7, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Monthly News Roundup - March 2015
FDA Approves First Biosimilar Product Zarxio On Friday, March 6th the U.S. Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz), the first U.S. approved biosimilar. Zarxio, the biosimilar for Amgen’s filgrastim... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 31, 2015 Category: Pharmaceuticals Source Type: news

Amgen to appeal rejection of bid to block Novartis biosimilar drug
SAN FRANCISCO (Reuters) - Amgen Inc will appeal the rejection of its bid to block the sale of Novartis AG's biosimilar form of Neupogen, Amgen's blockbuster drug used to prevent infections in cancer patients, according to a court filing on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - March 25, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

​Judge rejects Amgen bid to stop biosimilar drug
A federal judge has denied Amgen’s Inc.’s request to temporarily halt the sale of Novartis AG’s biosimilar cancer drug recently approved by the Food and Drug Administration. Earlier this month, the FDA approved Zarxio, Novartis’ version of Amgen’s Neupogen cancer drug, the first time the agency has approved a biosimilar drug in the U.S. The approval clears the way for various drugmakers to pursue the manufacture of biosimilar medicines, which can cost 20 to 30 percent less than the original… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 20, 2015 Category: Pharmaceuticals Source Type: news

​Judge rejects Amgen bid to stop biosimilar drug
A federal judge has denied Amgen’s Inc.’s request to temporarily halt the sale of Novartis AG’s biosimilar cancer drug recently approved by the Food and Drug Administration. Earlier this month, the FDA approved Zarxio, Novartis’ version of Amgen’s Neupogen cancer drug, the first time the agency has approved a biosimilar drug in the U.S. The approval clears the way for various drugmakers to pursue the manufacture of biosimilar medicines, which can cost 20 to 30 percent less than the original… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - March 20, 2015 Category: Biotechnology Source Type: news

U.S. judge rejects Amgen bid to block 'biosimilar' Neupogen
NEW YORK (Reuters) - A U.S. judge on Thursday denied Amgen Inc's bid to block the sale of Novartis AG's recently approved "biosimilar" form of Neupogen, Amgen's blockbuster drug used to prevent infections in cancer patients. (Source: Reuters: Health)
Source: Reuters: Health - March 19, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Zarxio (Filgrastim-sndz Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 12, 2015 Category: Drugs & Pharmacology Source Type: news

7 Bay Area drugs that face competition from cheaper biotech 'generics'
Call them biosimilars, copycats, generics or follow-on biologics, but the age of cheaper versions of biotech drugs is on us. Just last week, the Food and Drug Administration OK'd Zarxio — the first so-called biosimilar to win FDA approval— from Novartis AG (NYSE: NVS). Zarxio is a version of the Amgen Inc. (NASDAQ: AMGN) drug Neupogen, which increases infection-fighting white blood cell production in chemotherapy patients. See our 'generics' slideshow.>>>> At stake are tens of billions of… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - March 9, 2015 Category: American Health Authors: Ron Leuty Source Type: news

FDA Approves First Biosimilar Product (FREE)
By Kristin J. Kelley Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH The FDA has approved the first biosimilar product in the U.S. — filgrastim-sndz (marketed as Zarxio).A biosimilar is a … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - March 9, 2015 Category: Primary Care Source Type: news

Novartis's Sandoz receives FDA approval for biosimilar Zarxio
Novartis subsidiary Sandoz has received approval from the US Food and Drug Administration (FDA) for its Zarxio (filgrastim-sndz) for all indications included in the reference product's label. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - March 9, 2015 Category: Pharmaceuticals Source Type: news

First Copycat Biotech Drug Spurs $250B Obamacare Savings
The first U.S. approval of the “generic” biologic prescription version of the widely prescribed anti-infective cancer medicine Neupogen officially opens the door to a new era in cheaper drugs that could save the U.S. health care system tens of billions of  dollars a year. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - March 7, 2015 Category: Pharmaceuticals Authors: Bruce Japsen Source Type: news

First Biosimilar, a Filgrastim Copycat, Is Approved
(MedPage Today) -- Zarxio will compete against Amgen's Neupogen, but price impact still unclear. (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 6, 2015 Category: American Health Source Type: news

FDA Approves First US Biosimilar; Hold Your Breath On Cost Savings
The long-anticipated approval of the first biosimilar drug ? a sort of generic biotechnology drug ? occurred this morning. The FDA approved Sandoz's version of the white blood cell growth hormone, filgrastim, the analog of Amgen's Neupogen. But after all of this effort, will it really be less expensive? (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - March 6, 2015 Category: Pharmaceuticals Authors: David Kroll Source Type: news

First Biosimilar Approved in US: Filgrastim-sndz (Zarxio)First Biosimilar Approved in US: Filgrastim-sndz (Zarxio)
The first biosimilar product approved in the United States is filgrastim-sndz (Zarxio, Sandoz/Novartis), which was found to be similar to Amgen's Neupogen. News Alerts (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 6, 2015 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 6, 2015 Category: American Health Source Type: news

Biosimilars: More Treatment Options Are on the Way
The Food and Drug Administration (FDA) is approving Zarxio (filgrastim-sndz), the first biosimilar product (or biosimilar), and expects to approve others in the months ahead. What are biosimilars? How will they affect patient treatment? (Source: FDA Consumer Updates)
Source: FDA Consumer Updates - March 6, 2015 Category: Consumer Health News Source Type: news

Amgen Urges Court to Block Novartis Neupogen Biosimilar Launch
Amgen Inc. is seeking a preliminary injunction against Sandoz, a subsidiary of Novartis AG, over its application for the biosimilar version of Amgen’s blockbuster drug, Neupogen. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 10, 2015 Category: Pharmaceuticals Source Type: news

Accord Healthcare launches their first biopharmaceutical product in Europe: Accofil® (filgrastim)
Accord Healthcare is pleased to announce the launch of their first European approved biopharmaceutical product Accofil®, indicated for the treatment of chemotherapy induced neutropenia. (Source: Pharmacy Europe)
Source: Pharmacy Europe - January 29, 2015 Category: Drugs & Pharmacology Authors: Annabel De Coster Tags: *** Editor's Pick Practical therapeutics Cost effectiveness Industry News Haematology Oncology biopharmaceutical chemotherapy induced neutropenia filgrastim hiv Latest News peripheral blood progenitor cells Source Type: news

D.C. Week: House Passes Mandate Bill, Biosimilar Gets Thumbs Up
(MedPage Today) -- Bill would restrict ACA employer mandate; FDA advisers back Neupogen copy. (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - January 10, 2015 Category: American Health Source Type: news

Granix (Tbo-filgrastim Injection, for Subcutaneous Use) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 9, 2015 Category: Drugs & Pharmacology Source Type: news

FDA Advisory Committee Endorses Neupogen Biosimilar
(MedPage Today) -- Outlook good for biosimilars under abbreviated pathway. (Source: MedPage Today OB/GYN)
Source: MedPage Today OB/GYN - January 8, 2015 Category: OBGYN Source Type: news

Biosimilar Filgrastim Recommended for Approval in US Biosimilar Filgrastim Recommended for Approval in US
A biosimilar filgrastim (Novartis) has been recommended for approval in the US, after it was found not clinically different from Amgen's Neupogen. News Alerts (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - January 8, 2015 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

FDA panel unanimously backs Novartis' copy of Amgen's Neupogen
(Reuters) - A panel to the U.S. Food and Drug Administration unanimously backed the approval of Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen, setting the stage for the regulator's first approval of a biosimilar. (Source: Reuters: Health)
Source: Reuters: Health - January 7, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Why The FDA Panel's Nod To Sandoz's Filgrastim (Zarzio) Is Good News For Patients
The implications extend beyond cancer drugs. Biosimilars have the potential to significantly reduce the costs of modern health care for people with all kinds of illness (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 7, 2015 Category: Pharmaceuticals Authors: Elaine Schattner Source Type: news

For First Time, F.D.A. Panel Approves Generic Copy of Costly Biologic Drug
The group of experts endorsed a close version of the cancer drug Neupogen, which could open the door to more such biosimilar medicines. (Source: NYT Health)
Source: NYT Health - January 7, 2015 Category: Consumer Health News Authors: By SABRINA TAVERNISE Tags: United States Drugs (Pharmaceuticals) Food and Drug Administration Neupogen Generic Brands and Products Source Type: news

FDA Panel to Consider Biosimilar for Filgrastim
(MedPage Today) -- FDA staff are strongly supportive in pre-meeting report. (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - January 7, 2015 Category: Primary Care Source Type: news

FDA Finds No Clinical Differences in Novartis Biosimilar of Amgen Drug
Documents released in advance of an FDA advisory meeting stated no difference between Neupogen and Sandoz biosimilar (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - January 6, 2015 Category: Pharmaceuticals Source Type: news