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:10/30/2014)... Global polyvinyl chloride (PVC) demand registered a ... 2008-2009, especially in North America and Europe. However, the ... to a growing trend. , The largest chunk of ... construction segment. In 2013, the key PVC application spheres ... rigid film. Moreover, the PVC was consumed in the ...
(Date:10/30/2014)... October 30, 2014 SoundConnect ... provider, offers Office 365 end users the key ... complete phone system by adding voice enablement and ... includes Lync Online, a communication tool that includes ... With hosted voice, O365 becomes a comprehensive unified ...
(Date:10/30/2014)... 2014 Spartan Bioscience announced today that ... System . It detects CYP2C19 genetic mutations in less ... The Spartan RX CYP2C19 System is the first near-patient ... in Canada. Due to the system’s ease of use, ... by healthcare professionals such as doctors, nurses, pharmacists, and ...
(Date:10/30/2014)... Ras Al Khaimah, UAE (PRWEB) October 30, 2014 ... the appointment of Dr. James A. Manganello, Chairman of the ... (NSCEC) of The Bahamas. The appointment was made by ... The Bahamas on September 24th, 2014. , More ... Cell Therapy and Research Bill , Prime Minister Perry Christie ...
Breaking Biology Technology:Global Polyvinyl Chloride Demand Is on Upward Trend Now, Says Merchant Research & Consulting in Its Topical Study 2Global Polyvinyl Chloride Demand Is on Upward Trend Now, Says Merchant Research & Consulting in Its Topical Study 3SoundConnect Launches Voice Enablement and Hybrid Audio Conferencing for Office 365 2SoundConnect Launches Voice Enablement and Hybrid Audio Conferencing for Office 365 3Health Canada approves first near-patient DNA test for personalized medicine 2Health Canada approves first near-patient DNA test for personalized medicine 3Grace Century’s Stem Cell Biobank Project Announces Chairman’s Appointment to National Stem Cell Ethics Committee of The Bahamas 2Grace Century’s Stem Cell Biobank Project Announces Chairman’s Appointment to National Stem Cell Ethics Committee of The Bahamas 3
... (EMBL) discovered a new way to make use of drugs, ... how similar the side effects of different drugs are and ... molecule. The study, published in Science this week, ... often share target proteins, modes of action and unpleasant side ...
... ATRC ), a medical device company and a leader ... the second,quarter ended June 30, 2008 on Tuesday, August 5, ... a.m. ET on Tuesday,August 5, 2008 to discuss second quarter ... be available online from the investor relations,page of AtriCure,s corporate ...
... increased 38% to $42.3 million ... income rose 30% to $14.2 million, SHANGHAI, ... Board: CHBT) ("China-Biotics", "the,Company"), a leading Chinese firm ... of probiotics products,today announced its financial results for ...
Cached Biology Technology:Teaching old drugs new tricks 2AtriCure Announces Web Cast and Conference Call of Second Quarter 2008 Financial Results 2China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 2China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 3China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 4China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 5China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 6China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 7China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 8China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 9China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 10China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 11China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 12China-Biotics, Inc. Reports Fourth Quarter and Full Year Fiscal 2008 Financial Results 13
(Date:10/31/2014)... a new test that can distinguish between birds that ... influenza virus or "bird flu" with those that have ... in the fight against this often fatal strain of ... of South East Asia, particularly Indonesia and Vietnam. , ... to humans and the threat of a pandemic if ...
(Date:10/31/2014)... , Oct. 30, 2014  HITLAB SM ... pleased to announce its inaugural HITLAB Innovators Summit ... University,s Low Library. HITLAB will partner with the ... Wellness, Blueprint Health, ProtoHack, Columbia Business School Alumni ... and Columbia Industrial Engineering and Operations Research, bringing ...
(Date:10/30/2014)... a $1.04 million grant from the U.S. Army ... osteoarthritis using a patient,s own stem cells, spurred ... polymers., Liping Tang, a bioengineering professor and interim ... is primarily focused on helping soldiers who are ... if we inject microscaffolding that we,ve developed into ...
Breaking Biology News(10 mins):New step towards eradication of H5N1 bird flu 2HITLAB Announces Inaugural HITLAB Innovators Summit 2HITLAB Announces Inaugural HITLAB Innovators Summit 3UTA researcher uses microscaffolding injections to mend cartilage, prevent osteoarthritis 2
... medication robbed Elma Phifer of her vision two decades ago ... reduced the ability of her eyes to soothe their damaged ... family and friends to help her do many of the ... twenty years and several life milestones later, Elma is able ...
... share a genetic profile that appears to be unique ... researchers at Cincinnati Children's Hospital Medical Center. The discovery ... specifically tailored to children who suffer from the severest ... Feb. 10 issue of the Journal of Allergy and ...
... throw a wrench in the transmissions of several speed demons ... Medicine in St. Louis and Harvard University have identified a ... slow cell invasion by malaria and other parasites known as ... March 15 issue of Proceedings of the National Academy of ...
Cached Biology News:Artifical cornea lets woman blind 20 years see 2Artifical cornea lets woman blind 20 years see 3Artifical cornea lets woman blind 20 years see 4Asthma gene clusters identified 2Asthma gene clusters identified 3Protein offers way to stop microscopic parasites in their tracks 2Protein offers way to stop microscopic parasites in their tracks 3
PMM2 Immunogen: PMM2 (NP_000294, 47 a.a. ~ 112 a.a) partial recombinant protein with GST tag. Storage: -20 C, Avoid Freeze/Thaw Cycles *Available for distribution in the US only...
HOXC11 Antibody...
Rabbit polyclonal to Raf1 ( Abpromise for all tested applications). entrezGeneID: 5894 SwissProtID: P04049...
Sheep polyclonal to hCG beta core fragment ( Abpromise for all tested applications). Antigen: Full length native protein (purified) from human urine. Entrez GeneID: 1082 Swiss Protein ID...
Biology Products: