Navigation Links
ASBM Survey Reveals Key Safety Concern Associated with Biosimilar Naming; Urges Distinct Naming Requirement
Date:9/13/2012

WASHINGTON, Sept. 13, 2012 /PRNewswire/ -- The Alliance for Safe Biologic Medicines (ASBM) today announced the results of a new survey on physician opinions relating to biologics and biosimilars. ASBM Chairman, Dr. Richard O. Dolinar, presented key findings during the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C., where he urged the FDA to make patient-safety the cornerstone of the biosimilars pathway.

The survey examined physician practices and perspectives with regard to biosimilar medicine identification and substitution – policy issues that remain unresolved and will have a fundamental impact on patient safety.  Over 350 endocrinologists, dermatologists, oncologists, rheumatologists, nephrologists and neurologists – all specialties that prescribe biologics – responded to the survey.   Key findings from the physician survey demonstrate that patient safety must be a priority for all biosimilar policies.

  • Inappropriate substitution is a major risk if different biologics have the same scientific name.
    • 64% of surveyed physicians assume if products have the same name a patient can be safely switched from one product to another during treatment. 
    • More than 76% view products with the same scientific name as structurally identical.
  • Names are the primary means of product identification for physicians.
    • The vast majority (99%) of physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events. 
    • Less than 1% of prescribers use national drug code numbers for records or reporting. 
  • Physicians are very concerned about a patient being switched from one biologic to another. 
    • 85% of responding physicians want the authority to designate a biologic medicine as "Dispensed as Written", just as they have it for chemical products.
    • 86% of physicians want to be notified BEFORE a patient is switched to a biologic other than the one prescribed EVEN IF there are no known concerns associated with the product.

Dr. Dolinar, chairman of the Alliance, released the following statement about the conference and the survey results:

"In the past 30 years, biologic medicines have revolutionized the treatment of patients with many diseases – but making copies of these highly complex medicines presents significant challenges for physicians and regulators.  This survey provides important information for effectively addressing these challenges.  Biologics are produced from living cells and copies will be only similar, not identical to the original.  This survey clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients. 

"We have been very supportive of the FDA's efforts to create a pathway that ensures biosimilars are safe and effective for patients.  This survey demonstrates the potential safety consequences of giving different biologic products the same scientific name.  In order to avoid inappropriate substitution, all biologics should be required to have distinct names."

Biologics are used to treat cancer, rheumatoid arthritis and other debilitating diseases. On February 9, 2012, the FDA announced the publication of draft guidance documents relating to the developments of biosimilars, which are similar to, but not exact copies of biologics. The guidance documents were a significant step in establishing a biosimilars pathway and as the FDA moves forward, ASBM will continue to work to ensure patient safety remains the priority.

The survey was conducted by Industry Standard Research. Read the study here.

About the Alliance for Safe Biologic Medicines

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org

CONTACT: (703) 851-9116
media@safebiologics.org


'/>"/>
SOURCE The Alliance for Safe Biologic Medicines
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. According to New Survey, Most Men are Not Proactive about Their Health Despite the Desire to Live Long Lives
2. Fenwick & West Life Science Venture Financing Survey Shows Mild Improvement in Valuations Amid Overall Difficult Financing Environment
3. New Survey Reveals How Patients Choose Their Pharmacy; AccentHealth Garners Consumer Insights from the Waiting Room
4. Survey: Hospital Executives Nationwide Facing Operating Room Case Volume Increases, Seeking Greater Efficiency through Healthcare Information Technology (HIT)
5. Heraeus Survey Invites Customers to Share "What they Really Think"
6. Diplomat Specialty Pharmacys 2012 Physician Satisfaction Survey Results Affirm Success of Companys Education & Training Program
7. U.S. End-User Dental Materials Survey Report 2012
8. U.S. Physician Survey: Stents by Brand, Length, Diameter, Type and Coating 2012
9. Hologic Breast Tomosynthesis (3D Mammography) System Places First in KLAS Annual Survey of Mammography Equipment Users
10. Buyer Spend Activity and Procurement Behaviors and Strategies in the Pharmaceutical Industry - 2012-2013 : Survey Intelligence
11. Supplier Marketing Spend Activity, Marketing and Sales Behaviors and Strategies in the Medical Devices Industry - 2012-2013 : Survey Intelligence
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... 19, 2017 The global  pacemaker market  is expected to ... View Research, Inc. The heightening prevalence of cardiac conditions coupled with the availability ... globally. In addition, technological enhancements in these devices are supporting the expansion of ... ... Grand View Research Logo ...
(Date:1/19/2017)... , Jan. 18, 2017  ViewRay, Inc. ... world,s first and only clinical MRI-guided radiation therapy ... proceeds of approximately $26.1 million through a private ... Capital Management led the financing and was joined ... Advisors, LLC and Kearny Venture Partners, and an ...
(Date:1/19/2017)... 2017  Magnetic Insight Inc., leader in magnetic ... agreement with inviCRO LLC to develop intuitive image ... based on inviCRO,s VivoQuant™ visualization and post processing ... complete MPI solution package with the Momentum MPI ... imaging in vivo. MPI is a ...
Breaking Medicine Technology:
(Date:1/19/2017)... PETALUMA, CA (PRWEB) , ... January 19, 2017 ... ... new Tranquility acoustic and privacy panel system. , The Tranquility privacy panel ... to a collaborative office environment. Tranquility panels help reduce noise and provide the ...
(Date:1/19/2017)... Ashland, VA (PRWEB) , ... January 19, 2017 , ... ... planning services to the eastern Virginia region, is inaugurating a charity event to honor ... community. , While on duty last year, Chad Phillip Dermyer and his fellow officers ...
(Date:1/19/2017)... (PRWEB) , ... January 19, 2017 , ... ... Reproductive Endocrinologists at Reproductive Medicine Associates of Connecticut (RMACT) have earned “Top ... Cynthia Murdock and Dr. Shaun Williams have each been chosen by their peers ...
(Date:1/19/2017)... ... ... Sales Focus Inc. (SFI), a Maryland-based sales outsourcing company, announced today that ... 20 years SFI has been recognized as the world’s leader in Intelligent Sales Outsourcing ... US market. The new clients include: Panacea Pro, Campseekers, Contentmart, Stress Pal, Ariello, ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... lines and wrinkles. Few people know that popular cosmetic fillers can ... Buckley, who is medical director of the MilfordMD Cosmetic Dermatology Surgery & Laser ...
Breaking Medicine News(10 mins):