BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Drug Information Association and Food & Drug Law Institute Collaborate on First Comprehensive Conference on Biosimilars Since the Enactment of BPCIA


3/17/2011 10:15:35 AM

HORSHAM, PA, USA—MARCH 17, 2011—DIA, in cooperation with the Food and Drug Law Institute(FDLI), will host Future of Biosimilars in the US: Legal, Regulatory, Scientific, Regulatory, Clinical and Payer Issues from May 4-5 in North Bethesda, MD.

FDA, industry, lawyers, academics, clinicians, payers, and patients will discuss the challenges and opportunities associated with the introduction of biosimilars to the US, including:

- Level of similarity and extent of physiochemical and biological data required to demonstrate the follow-on protein to be “highly similar” to the innovator product and to qualify as a biosimilar

- Value of nonclinical testing for the demonstration of “biosimilarity"

- Criteria to achieve interchangeability status

- Exclusivity under the BPCIA

- Supplemental qualifications for exclusivity

- Intellectual property protection and litigation

- Labeling and nomenclature need to be applied to biosimilars

- Patient access to expensive biological medicines and extent that patient choice becomes compromised or even severely limited

“The Biologics Price Competition and Innovation Act (BPCIA) was enacted into law as part of US healthcare reform, establishing an approval pathway for biosimilar biological products in the US,” explains Program Co-chair Philip L. Huang, MBA, MD, Vice President, Vaccine Strategy & Innovation, Merck & Co., Inc. “This Act and the way it is implemented will have a huge impact on the development and availability of biological medicines in the US, both from an intellectual property and market access perspective.”

Register for Future of Biosimilars in the US.

ABOUT DIA

DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES