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:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... 23, 2016 Bracket , a leading clinical ... generation clinical outcomes platform, Bracket eCOA (SM) 6.0, at ... 26 – 30, 2016 in Philadelphia , ... Outcome Assessment product of its kind to fully integrate with ... Bracket eCOA 6.0 is a flexible platform for electronic clinical ...
(Date:6/23/2016)... -- Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in ... . ... ... ... Astellas is ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
(Date:6/24/2016)... ... 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida ... their peers for this recognition are considered among the top 2 percent of lawyers ... as members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark ...
(Date:6/24/2016)... ... ... Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair ... hour by 2020 and then adjusting it yearly to increase at the same rate as ... the wage floor does not erode again, and make future increases more predictable. , The ...
Breaking Medicine News(10 mins):