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
In his session at 21st Cloud Expo, Raju Shreewastava, founder of Big Data Trunk, provided a fun and simple way to introduce Machine Leaning to anyone and everyone. He solved a machine learning problem and demonstrated an easy way to be able to do machine learning without even coding. Raju Shreewastava is the founder of Big Data Trunk (www.BigDataTrunk.com), a Big Data Training and consulting firm with offices in the United States. He previously led the data warehouse/business intelligence and B...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
Smart cities have the potential to change our lives at so many levels for citizens: less pollution, reduced parking obstacles, better health, education and more energy savings. Real-time data streaming and the Internet of Things (IoT) possess the power to turn this vision into a reality. However, most organizations today are building their data infrastructure to focus solely on addressing immediate business needs vs. a platform capable of quickly adapting emerging technologies to address future ...
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, discussed the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, application p...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Is advanced scheduling in Kubernetes achievable?Yes, however, how do you properly accommodate every real-life scenario that a Kubernetes user might encounter? How do you leverage advanced scheduling techniques to shape and describe each scenario in easy-to-use rules and configurations? In his session at @DevOpsSummit at 21st Cloud Expo, Oleg Chunikhin, CTO at Kublr, answered these questions and demonstrated techniques for implementing advanced scheduling. For example, using spot instances and co...
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The need for greater agility and scalability necessitated the digital transformation in the form of following equation: monolithic to microservices to serverless architecture (FaaS). To keep up with the cut-throat competition, the organisations need to update their technology stack to make software development their differentiating factor. Thus microservices architecture emerged as a potential method to provide development teams with greater flexibility and other advantages, such as the abili...
Product connectivity goes hand and hand these days with increased use of personal data. New IoT devices are becoming more personalized than ever before. In his session at 22nd Cloud Expo | DXWorld Expo, Nicolas Fierro, CEO of MIMIR Blockchain Solutions, will discuss how in order to protect your data and privacy, IoT applications need to embrace Blockchain technology for a new level of product security never before seen - or needed.
Leading companies, from the Global Fortune 500 to the smallest companies, are adopting hybrid cloud as the path to business advantage. Hybrid cloud depends on cloud services and on-premises infrastructure working in unison. Successful implementations require new levels of data mobility, enabled by an automated and seamless flow across on-premises and cloud resources. In his general session at 21st Cloud Expo, Greg Tevis, an IBM Storage Software Technical Strategist and Customer Solution Architec...
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...
"As we've gone out into the public cloud we've seen that over time we may have lost a few things - we've lost control, we've given up cost to a certain extent, and then security, flexibility," explained Steve Conner, VP of Sales at Cloudistics,in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...