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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

After FDA delay, Redwood City 'biosimilar' company sheds third of workforce
Coherus BioSciences Inc., stopped earlier this month in its efforts to offer a lower-cost version of a drug for cancer chemotherapy patients, will lay off 30 percent of its workforce. The Redwood City company (NASDAQ: CHRS) said it cut 51 jobs after the Food and Drug Administration asked it to reanalyze some data from clinical trials and provide more information about manufacturing. Coherus leaders had hoped to win FDA approval this month of the drug, its version of Amgen Inc.' s Neulasta, and hit… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 28, 2017 Category: Biotechnology Authors: Ron Leuty Source Type: news

After FDA delay, Redwood City 'biosimilar' company sheds third of workforce
Coherus BioSciences Inc., stopped earlier this month in its efforts to offer a lower-cost version of a drug for cancer chemotherapy patients, will lay off 30 percent of its workforce. The Redwood City company (NASDAQ: CHRS) said it cut 51 jobs after the Food and Drug Administration asked it to reanalyze some data from clinical trials and provide more information about manufacturing. Coherus leaders had hoped to win FDA approval this month of the drug, its version of Amgen Inc.' s Neulasta, and hit… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 28, 2017 Category: American Health Authors: Ron Leuty Source Type: news

After FDA delay, Peninsula 'biosimilar' company sheds third of workforce
Coherus BioSciences Inc., stopped earlier this month in its efforts to offer a lower-cost version of a drug for cancer chemotherapy patients, will lay off 30 percent of its workforce. The Redwood City company (NASDAQ: CHRS) said it cut 51 jobs after the Food and Drug Administration asked it to reanalyze some data from clinical trials and provide more information about manufacturing. Coherus leaders had hoped to win FDA approval this month of the drug, its version of Amgen Inc.' s Neulasta, and hit… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 28, 2017 Category: Biotechnology Authors: Ron Leuty Source Type: news

After FDA delay, Peninsula 'biosimilar' company sheds third of workforce
Coherus BioSciences Inc., stopped earlier this month in its efforts to offer a lower-cost version of a drug for cancer chemotherapy patients, will lay off 30 percent of its workforce. The Redwood City company (NASDAQ: CHRS) said it cut 51 jobs after the Food and Drug Administration asked it to reanalyze some data from clinical trials and provide more information about manufacturing. Coherus leaders had hoped to win FDA approval this month of the drug, its version of Amgen Inc.' s Neulasta, and hit… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 28, 2017 Category: American Health Authors: Ron Leuty Source Type: news

Copycat 'biosimilars' win fast track, but FDA says this Bay Area company must slow down
Despite a Supreme Court decision shaving six months off the time it would take a maker of a so-called biosimilar to get to market, Coherus BioSciences Inc. lost nearly a quarter of its value Monday as regulators held off on approving its lower-cost biologic copycat version of a blockbuster brand-name drug. Redwood City-based Coherus (NASDAQ: CHRS) had asked the Food and Drug Administration to approve CHS-1701, its version of Amgen Inc.'s Neulasta. But the FDA said Monday that it needed Coherus to… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 12, 2017 Category: American Health Authors: Ron Leuty Source Type: news

Copycat 'biosimilars' win fast track, but FDA says this Bay Area company must slow down
Despite a Supreme Court decision shaving six months off the time it would take a maker of a so-called biosimilar to get to market, Coherus BioSciences Inc. lost nearly a quarter of its value Monday as regulators held off on approving its lower-cost biologic copycat version of a blockbuster brand-name drug. Redwood City-based Coherus (NASDAQ: CHRS) had asked the Food and Drug Administration to approve CHS-1701, its version of Amgen Inc.'s Neulasta. But the FDA said Monday that it needed Coherus to… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 12, 2017 Category: Biotechnology Authors: Ron Leuty Source Type: news

FDA rejects Coherus' biosimilar for Amgen's Neulasta
(Reuters) - Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration (FDA) denied the approval of its biosimilar for Amgen Inc's blockbuster treatment, Neulasta, which fights infections in cancer patients. (Source: Reuters: Health)
Source: Reuters: Health - June 12, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA rejects Coherus's biosimilar for Amgen's Neulasta
(Reuters) - Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration denied the approval of its biosimilar for Amgen Inc's Neulasta, which fights infections in cancer patients. (Source: Reuters: Health)
Source: Reuters: Health - June 12, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Amgen Launches Neulasta ® (pegfilgrastim) Onpro® NARRATIVES
Online News Resource Highlights Importance of Patient and Care Team Dialogue THOUSAND OAKS, Calif., April 18, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the launch of Neulasta® (pegfilgrastim) Onpro® NARRATIVES, an online media resource about the value of a cancer care team that provides comprehensive support for patients receiving strong chemotherapy. Intended to support conversations between cancer patients undergoing strong chemotherapy and their healthcare team about potential risk for infection due to a low white blood cell count, Neulasta Onpro NARRATIVES shares personal cancer stories ...
Source: Amgen News Release - April 18, 2017 Category: Pharmaceuticals Tags: Uncategorized 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

This Is What Obamacare's Critics Won't Admit Or Simply Don't Understand
THOUSAND OAKS, California ― Maryann Hammers is likely to die from ovarian cancer someday. But she hopes someday won’t come anytime soon. Hammers, 61, received the diagnosis in late 2013, and doctors told her that it was stage 3-C, which meant that she could live for many years with the right treatment and a little luck. So far, she’s had both. She’s in remission for the second time, and her last course of chemotherapy ended a year and a half ago. But recent blood tests detected elevated levels of a protein associated with tumors, she explained when we met a few weeks ago. “Maybe it’s a fluk...
Source: Healthy Living - The Huffington Post - February 18, 2017 Category: Consumer Health News 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

Analyst: Insulet ’ s drug-delivery biz a long-term growth driver
Insulet’s (NSDQ:PODD) drug-delivery business will be a long-term growth driver for the company by as much as 20% a year for the next few years, according to Leerink Partners analysts. Billerica, Mass.-based Insulet generates 86% of its revenue from its OmniPod insulin delivery device, according to Leerink. The OmniPod technology could be easily adapted to other drugs, according to the investment bank, which cited Insulet’s partnership with Amgen (NSDQ:AMGN) as a foundation for other wearable drug-delivery products. “There are a significant number of injectable drugs that are nearing patent expiration over...
Source: Mass Device - October 3, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Business/Financial News Drug-Device Combinations Amgen Insulet Corp. Leerink Partners Source Type: news

FDA Rejects Novartis Biosimilar App for Amgen Neulasta
The U.S. FDA has declined to approve Novartis' application for a biosimilar copy of Amgen's blockbuster, Neulasta. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 19, 2016 Category: Pharmaceuticals Source Type: news

FDA knocks back Novartis copy of Amgen's drug Neulasta
(Reuters) - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections in cancer patients, the Swiss drugmaker said on Tuesday. (Source: Reuters: Health)
Source: Reuters: Health - July 19, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

Cinfa Biotech reports positive top-line clinical trial results of B12019 to treat neutropenia
Spanish biosimilars company Cinfa Biotech has reported positive top-line clinical trial results of B12019, a biosimilar version of Neulasta (pegfilgrastim), to treat chemotherapy-induced neutropenia. (Source: Drug Development Technology)
Source: Drug Development Technology - July 4, 2016 Category: Pharmaceuticals Source Type: news

Neulasta (Pegfilgrastim) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 9, 2016 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

Use and Side Effects of Neulasta During Breast...
How is neulasta used during breast cancer chemotherapy, and what are some of its side effects and risks? (Source: About.com Breast Cancer)
Source: About.com Breast Cancer - March 21, 2016 Category: Cancer & Oncology Authors: breastcancer.guide at about.com Tags: health 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

EU agency accepts Sandoz application for pegfilgrastim biosimilar
ZURICH (Reuters) - The European Medicines Agency (EMA) has accepted an application to review Sandoz's biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulating factor, Sandoz parent Novartis said on Thursday. (Source: Reuters: Health)
Source: Reuters: Health - February 11, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

Novartis: Study shows copycat works just as well as Amgen drug
ZURICH (Reuters) - Novartis's copycat version of Amgen's Neulasta worked just as well as the original drug in preventing a condition that can lead to infections among breast cancer sufferers, the Swiss company said in a statement on Monday. (Source: Reuters: Health)
Source: Reuters: Health - December 7, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

FDA accepts Sandoz's BLA for biosimilar pegfilgrastim to treat non-myeloid cancer
The US Food and Drug Administration (FDA) has accepted Sandoz's biologics licence application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulat… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - November 19, 2015 Category: Pharmaceuticals Source Type: news

Novartis biosimilar takes aim at Amgen drug Neulasta
ZURICH (Reuters) - The U.S. Food and Drug Administration has accepted Novartis unit Sandoz's submission for approval of a biosimilar version of U.S.-based Amgen's Neulasta drug that fights infections in cancer patients, the Swiss group said on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - November 18, 2015 Category: Consumer Health News Tags: healthNews 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

Intas Pharma expects US approval for Neulasta biosimilar this year
India's Intas Pharmaceuticals Ltd could get approval this year to launch a version of Amgen Inc's white blood cell boosting Neulasta drug in the United States. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 18, 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

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

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

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

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

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 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

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

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

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

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

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