Navigation Links
Recall of Anemia Drug Omontys Rings Alarm Over Biosimilars
Date:2/27/2013

ATLANTA, Feb. 27, 2013 /PRNewswire-USNewswire/ -- Makers of innovative biologics have legitimate reason to sound alarms about automatic substitution of biosimilars that have not proven their interchangeability – and it's not just because of the potential impact to their bottom line. That point was driven home by the recent recall of Affymax Inc. and Takeda Pharmaceutical Co. Ltd.'s anemia drug Omontys (peginesatide), according to BioWorld.

(Logo: http://photos.prnewswire.com/prnh/20120628/DC32901LOGO)

Though Omontys is not a biosimilar, the unexpected postmarketing reports of serious hypersensitivity reactions (three patient deaths) linked to the erythropoiesis-stimulating agent (ESA) served as a reminder of the variability of biologics, their sensitivity to minute manufacturing changes and the difficulty of catching a rare safety signal in the full-blown biologic development process – let alone an abbreviated biosimilar path, as noted in a blog post by BioWorld Washington Editor Mari Serebrov

This should give the FDA pause about its approach to biosimilar approval. Because of the variability of biologics, biotechs and patient advocacy groups have urged the agency to require safety data for biosimilars. While the FDA maintains that patient safety is its primary concern with any drug, it insists that since the reference biologic has demonstrated safety and efficacy, all a biosimilar must do is demonstrate similarity to the reference drug. The goal is not to require redundant clinical trials that would be expensive, unnecessary and unethical.

Neither the FDA nor most biotechs want the biosimilar path to fail. But they understand the complexities of making biologics, and they know that one disaster now could doom or indefinitely delay the new approval path.

Unfortunately, people unfamiliar
'/>"/>

SOURCE BioWorld
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Rust Gets Toyota Recalling Its Tacoma; Hub on Wheels Advises Car Owners to Deal With Any Other Car Rust Problem with Rusterizer
2. Zamansky & Associates LLC Investigates Affymax Inc. Over Its Recall of Omontys Due to Fatal Reactions
3. A mouse model brings new perspectives on Lafora disease
4. At-the-Market Offerings (ATM) of Life Sciences Companies Perform Well in Weak Follow-on Financing Environment of Third Quarter
5. Elsevier Collaborates With Prophecy Healthcare to Enhance Its Staff Development Offerings for Healthcare Organizations
6. TAKE Solutions Brings Together Leading Experts and TAKE Customers at “Converge 2012” to Discuss Business
7. Biodetection 2012 Conference Brings Together Leading Organizations from Around the World to Address Challenges & Technology Advances in Detection and Identification of Biological Threats in Washington, DC from June 28-29, 2012
8. ScaleMatrix Leads the Way Unveiling the Industry’s First Transparent Pricing Tool in Private Cloud Offerings
9. Finding Brings Scientists One Step Closer To Parkinsons Drug
10. Rusterizer Brings Out New Non-Toxic Rust Remover, Gives Samples of the Product
11. Elsevier Expands Access to Digital Offerings Through Collaboration with Follett
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... 23, 2014 StemGenex® , the ... the US aimed at improving the lives of patients ... study for Parkinson’s disease. StemGenex believes that a ... therapy are paramount when providing care to patients with ... stem cell therapy accessible to the millions of individuals ...
(Date:7/23/2014)... 2014 /PRNewswire/ - BioAmber Inc. (NYSE: ... chemicals, today announced that the underwriters of its common ... purchase an additional 420,000 shares of common stock ... share, less underwriting discounts and commissions, in connection ... 2,800,000 shares of common stock, bringing the expected ...
(Date:7/23/2014)... , July 23, 2014  GrowBLOX Sciences, Inc. (OTCQB: ... that it is filing for two medical marijuana dispensary locations ... are in addition to the Clark County, Nevada ... special use permit, as previously announced.  GrowBLOX Sciences, ... be submitting two new applications for dispensaries in the ...
(Date:7/23/2014)... With the ability to record continuously at over ... 15 minutes, Fastec Imaging has brought the same ease-of-use of ... “Finally, a high speed camera that can be used as ... lives.” proclaims Matt Kearney, VP of Sales for Fastec Imaging. ... and simplify the traditionally complicated workflow of a high speed ...
Breaking Biology Technology:StemGenex® Gives Hope to Parkinson’s Patients through New Stem Cell Clinical Study 2StemGenex® Gives Hope to Parkinson’s Patients through New Stem Cell Clinical Study 3BioAmber announces exercise in full of underwriters' option in connection with previously priced follow-on offering 2BioAmber announces exercise in full of underwriters' option in connection with previously priced follow-on offering 3GrowBLOX Sciences, Inc. Files for Two Additional Medical Marijuana Dispensaries in Las Vegas 2GrowBLOX Sciences, Inc. Files for Two Additional Medical Marijuana Dispensaries in Las Vegas 3Fastec Imaging Introduces the First High Speed Camcorder 2Fastec Imaging Introduces the First High Speed Camcorder 3
... /PRNewswire-FirstCall/ - On August 20, 2008,Oncothyreon Inc. (Nasdaq: ... a,letter from The Nasdaq Stock Market indicating that (i) ... on The NASDAQ Global Market,because it did not meet ... other things, that the market value of,its common stock ...
... with international ... and technology companies, TORONTO, Sept. 17 Aurillion, a ... Moreno as its vice president of sales and marketing. In ... grow the company,s business throughout the Americas, Europe,and Asia. He ...
... 17 Sigma-Aldrich Corporation,(Nasdaq: SIAL ) will be ... Wednesday, September 24th at 8:30 AM ET at the ... via live audio broadcast over the,Internet available at ... this file. For the webcast on, http://ir.sigmaaldrich.com users ...
Cached Biology Technology:Oncothyreon announces receipt of NASDAQ letter regarding compliance with NASDAQ Global Market listing standards 2Oncothyreon announces receipt of NASDAQ letter regarding compliance with NASDAQ Global Market listing standards 3Guillermo Moreno Named Aurillion's Vice President of Sales and Marketing 2
(Date:7/23/2014)... news release is available in German . ... and stability to cells, drive metabolic processes and transmit ... complex three-dimensional shapes. Scientists at the Max Planck Institute ... proteins can be constructed of similar amino acid chains ... that the proteins that exist today arose from common ...
(Date:7/23/2014)... BioCatch, the global leader in ... has been named in Gartner,s Market Guide for Online ... well-known Magic Quadrant for Web Fraud Detection. ... several vendors to deliver passive biometric analysis and predicted, ... feature of at least 30% of one-stop fraud detection ...
(Date:7/23/2014)... clinical use of induced pluripotent stem cell (iPSC) ... hindered by the risk of dysregulated cell growth, ... use etoposide treatment to halt teratoma formation in ... acute myocardial infarction, is demonstrated in an article ... peer-reviewed journal from Mary Ann Liebert, Inc., publishers. ...
Breaking Biology News(10 mins):Protein evolution follows a modular principle 2BioCatch Featured in Gartner's 2014 Online Fraud Detection Market Guide 2BioCatch Featured in Gartner's 2014 Online Fraud Detection Market Guide 3
... January 2014 Scientists from the Montreal Neurological ... two genes linked to hereditary Parkinson,s disease are ... The protective mechanism, which is reported in T ... arise from oxidative stress from mitochondria., "PINK1 and ...
... 21, JoVE, the Journal of Visualized Experiments , ... explored one of the most intriguing research questions facing ... protocol, titled Conducting Miller-Urey Experiments, is comprised of a ... Dr. Stanley Miller and Dr. Harold Urey in 1953. ...
... viral pathogen that typically infects plants has been found ... Researchers working in the U.S. and Beijing, China report ... journal of the American Society for Microbiology. The ... "resulted in the serendipitous detection of Tobacco Ringspot Virus, ...
Cached Biology News:Quality control of mitochondria as a defense against disease 2A 21st century adaptation of the Miller-Urey origin of life experiments 2Pathogenic plant virus jumps to honeybees 2
... Roches RTS AviTag E. coli Biotinylation Kit, Linear ... 100 E. coli expression kits. (Cat. No. 3 ... reagents to rapidly generate linear expression constructs by ... based on a combination of T7 RNA polymerase ...
... (GR) Competitor Assay Kits are ideal for ... The PolarScreen GR Competitor Assay Kits contain ... and one of the following proprietary fluorescent ... GS Red (red assay kit), or GS ...
... E. coli Biotinylation Kit, Plasmid is designed for ... coli expression kits. (Cat. No. 3 186 148, ... provides vectors for the easy introduction of a ... protein can be enzymatically mono-biotinylated by E. coli ...
... Exiqons LNA technology enables sensitive, fast ... on intact chromosomes. Short hybridisation ... fixed cells and chromosome spreads Multiplex ... Pre-validated probes Probes available ...
Biology Products: