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 with the differences between biologics and small molecule drugs, which are far less complex than biologics, too often equate biosimilars with generics. Since generics are unquestionably accepted as equivalent to small molecule reference drugs, they can be substituted automatically for the brand drug at the pharmacy. Yet even generics have had equivalency problems.

Editor's note: This is an excerpt from a BioWorld Perspectives Blog post. Read the complete post: http://bioworld.blogs.bioworld.com/.

BioWorld ‑ the industry's most trusted news service focused on the development of biologics for more than two decades ‑ has identified and profiled 139 key biosimilar developers with >276 biosimilars in their pipelines, according to The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies, a new report by BioWorld Data. Call for details (800) 477-6307.

Contact: Lynn Yoffee
404-262-5408
www.bioworld.com


'/>"/>
SOURCE BioWorld
Copyright©2012 PR Newswire.
All rights reserved

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:6/27/2016)... CA (PRWEB) , ... June 27, 2016 , ... ... for clinical trials, announced today the Clinical Reach Virtual Patient Encounter CONSULT ... care circle with the physician and clinical trial team. , Using the CONSULT module, ...
(Date:6/27/2016)... , June 27, 2016  Liquid Biotech ... the funding of a Sponsored Research Agreement with ... tumor cells (CTCs) from cancer patients.  The funding ... CTC levels correlate with clinical outcomes in cancer ... data will then be employed to support the ...
(Date:6/24/2016)... 2016 Epic Sciences unveiled a liquid ... to PARP inhibitors by targeting homologous recombination deficiency ... new test has already been incorporated into numerous ... types. Over 230 clinical trials are ... including PARP, ATM, ATR, DNA-PK and WEE-1. Drugs ...
(Date:6/23/2016)... WA (PRWEB) , ... June 23, 2016 , ... ... announces the release of its second eBook, “Clinical Trials Patient Recruitment and Retention ... recruitment and retention in this eBook by providing practical tips, tools, and strategies ...
Breaking Biology Technology:
(Date:4/26/2016)... LONDON , April 26, 2016 ... a product subsidiary of Infosys (NYSE: ... to integrate the Onegini mobile security platform with ... http://photos.prnewswire.com/prnh/20151104/283829LOGO ) The integration will ... to access and transact across channels. Using this ...
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
(Date:4/13/2016)... 13, 2016  IMPOWER physicians supporting Medicaid patients in ... new clinical standard in telehealth thanks to a new ... higi platform, IMPOWER patients can routinely track key health ... mass index, and, when they opt in, share them ... to a local retail location at no cost. By ...
Breaking Biology News(10 mins):