Welcome!

News Feed Item

Patient Safeguards Needed for Biosimilar Development

MISSION, KS -- (Marketwired) -- 08/08/14 -- (Family Features) Thanks to a provision in the Patient Protection and Affordable Care Act, efforts are underway to streamline licensing for medications known as "biosimilars," which are similar -- but not identical -- to cutting-edge biologic medicines. However, the development has some concerned about patient safety, especially among older Americans who tend to suffer from more chronic diseases, such as cancer, diabetes, and heart disease.

According to the U.S. Food and Drug Administration (FDA), a biosimilar is highly similar to a U.S.-licensed biological product (a wide range of items including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and proteins) that may have minor differences in clinically inactive components, but (supposedly) no clinically meaningful differences in terms of the safety, purity and potency. This is difficult to ensure because both biologics and biosimilars are derived from complex living organisms. Even different production facilities, shipping, or storage could create meaningful differences.

Again, biosimilars are highly similar but not identical to their biologic originator and should not be confused with generics. Generic medicines are traditional pharmaceutical medicines and have the same exact active ingredient as their originator; therefore patients can be switched easily from one to the other with the same outcome. However, it is possible that a biologic and a nearly identical biosimilar could have different reactions for the same patient.

A few weeks ago the FDA accepted the first application for a biosimilar, yet they have not released the safety standards, under which a biosimilar will be approved, an important step toward licensing these medicines for sale in the U.S. market.

With this important step on the horizon, some groups are focused on the importance of patient safeguards for biosimilar medications. RetireSafe, a leading grassroots organization advocating on behalf of America's seniors, recently commissioned a survey on the issue.

"When it comes to new biosimilar drugs, people are rightly concerned and want to keep their drugs safe and effective," said Thair Phillips, RetireSafe president. "A series of common-sense safeguards around new medicines in the form of a 'Safe Medicines Bill of Rights' will help protect vulnerable patients, in particular older Americans whose health needs make them especially reliant on prescription medications."

The RetireSafe survey found several significant gaps in knowledge and understanding among consumers, particularly regarding the relationship between biosimilars and generics, and how substitutions may be handled.

The survey also found overwhelming support for a strong set of patient safeguards:

  • 92 percent supported a requirement that drug companies test the safety of biosimilars for all conditions the drug will be used to treat.
  • 86 percent wanted a requirement that human clinical trials be conducted to ensure a given biosimilar is safe.
  • 90 percent supported a requirement that the name of the biosimilar be different than the original biologic medicine to allow for adequate tracking of any adverse reactions.
  • 91 percent want physicians be notified when a biosimilar is substituted for the original biologic drug they prescribed for their patient.
  • 94 percent believe that patients should be notified when a biosimilar is substituted for the original drug prescribed by their doctor.

For more information about biosimilars and the role they may play in your future health care, visit www.retiresafe.org or www.fda.gov.

About Family Features Editorial Syndicate
This and other food and lifestyle content can be found at www.editors.familyfeatures.com. Family Features is a leading provider of free food and lifestyle content for use in print and online publications. Register with no obligation to access a variety of formatted and unformatted features, accompanying photos, and automatically updating Web content solutions.

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=2654325

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Digital transformation has increased the pace of business creating a productivity divide between the technology haves and have nots. Managing financial information on spreadsheets and piecing together insight from numerous disconnected systems is no longer an option. Rapid market changes and aggressive competition are motivating business leaders to reevaluate legacy technology investments in search of modern technologies to achieve greater agility, reduced costs and organizational efficiencies. ...
In this presentation, you will learn first hand what works and what doesn't while architecting and deploying OpenStack. Some of the topics will include:- best practices for creating repeatable deployments of OpenStack- multi-site considerations- how to customize OpenStack to integrate with your existing systems and security best practices.
As organizations shift towards IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. Commvault can ensure protection, access and E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his general session at 18th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Part...
"With Digital Experience Monitoring what used to be a simple visit to a web page has exploded into app on phones, data from social media feeds, competitive benchmarking - these are all components that are only available because of some type of digital asset," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
It is ironic, but perhaps not unexpected, that many organizations who want the benefits of using an Agile approach to deliver software use a waterfall approach to adopting Agile practices: they form plans, they set milestones, and they measure progress by how many teams they have engaged. Old habits die hard, but like most waterfall software projects, most waterfall-style Agile adoption efforts fail to produce the results desired. The problem is that to get the results they want, they have to ch...
Personalization has long been the holy grail of marketing. Simply stated, communicate the most relevant offer to the right person and you will increase sales. To achieve this, you must understand the individual. Consequently, digital marketers developed many ways to gather and leverage customer information to deliver targeted experiences. In his session at @ThingsExpo, Lou Casal, Founder and Principal Consultant at Practicala, discussed how the Internet of Things (IoT) has accelerated our abilit...
For far too long technology teams have lived in siloes. Not only physical siloes, but cultural siloes pushed by competing objectives. This includes informational siloes where business users require one set of data and tech teams require different data. DevOps intends to bridge these gaps to make tech driven operations more aligned and efficient.
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service.
HyperConvergence came to market with the objective of being simple, flexible and to help drive down operating expenses. It reduced the footprint by bundling the compute/storage/network into one box. This brought a new set of challenges as the HyperConverged vendors are very focused on their own proprietary building blocks. If you want to scale in a certain way, let's say you identified a need for more storage and want to add a device that is not sold by the HyperConverged vendor, forget about it...
Digital Transformation is much more than a buzzword. The radical shift to digital mechanisms for almost every process is evident across all industries and verticals. This is often especially true in financial services, where the legacy environment is many times unable to keep up with the rapidly shifting demands of the consumer. The constant pressure to provide complete, omnichannel delivery of customer-facing solutions to meet both regulatory and customer demands is putting enormous pressure on...
The best way to leverage your CloudEXPO | DXWorldEXPO presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering CloudEXPO | DXWorldEXPO will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at CloudEXPO. Product announcements during our show provide your company with the most reach through our targeted audienc...
JETRO showcased Japan Digital Transformation Pavilion at SYS-CON's 21st International Cloud Expo® at the Santa Clara Convention Center in Santa Clara, CA. The Japan External Trade Organization (JETRO) is a non-profit organization that provides business support services to companies expanding to Japan. With the support of JETRO's dedicated staff, clients can incorporate their business; receive visa, immigration, and HR support; find dedicated office space; identify local government subsidies; get...
@DevOpsSummit at Cloud Expo, taking place November 12-13 in New York City, NY, is co-located with 22nd international CloudEXPO | first international DXWorldEXPO and will feature technical sessions from a rock star conference faculty and the leading industry players in the world.