Navigation Links
Newly released FDA draft guidelines for biosimilar drugs to be discussed at conference
Date:3/1/2012

On March 9, the New York Academy of Sciences will present "Scientific Considerations for Complex Drugs in Light of Established Regulatory Guidance." This full-day conference will explore current definitions, global scientific and regulatory hurdles, and future challenges for follow-on versions of complex drugs.

On February 9, 2012, the FDA released its much-anticipated new draft guidelines for implementing the Biologics Price Competition and Innovation Act of 2009, which called for an abbreviated approval pathway for biological products that are demonstrated to be "highly similar" to, or "interchangeable" with, a previously approved and regulated drug. However, current U.S. regulations do not make scientific distinctions between small-molecule drugs and non-biological complex drugs; although the latter may present many of the same scientific and clinical challenges to reproduce as biologics.

In light of the recently drafted approval guidelines for biosimilars in the U.S., and increased international concern for new follow-on biological and non-biological products currently defined as "interchangeable" in both established and emerging markets abroad, the Academy will bring together experts representing a variety of perspectives, including industry, regulatory agencies, physicians, and consumers. Representation from the FDA will provide an overview of the demonstration of therapeutic equivalence of complex drug products, which shall inform the day's broader discussions about the regulation of non-biological complex drugs.

Plenary sessions will address the most recent regulatory developments and experimental design, interchangeability, and immunogenicity issues for follow-on versions of complex drugs; featuring conversations led by Larry Lee, PhD, FDA; Ivana Knezevic, MD, PhD, World Health Organization; Huub Schellekens, MD, PhD, Utrecht University; Janet S. Wyatt, PhD, RN, FAANP, Institute of Pediatric Nursing and Arthritis Foundation; Jan Mueller-Berghaus, MD, Paul-Ehrlich-Institut; Beatriz Silva-Lima, PharmD, PhD, University of Lisbon; Chris Holloway, PhD, ERA Consulting Group; and Andrew D. Zelenetz, MD, PhD, Memorial Sloan-Kettering Cancer Center.

An international audience of basic researchers, policy makers, and regulatory and public health experts from academia, industry, government, and NGOs will participate in the conversation about the changing regulatory landscape for biological and non-biological complex drugs. The open format of the meeting, including multiple question and answer periods and a working lunch brainstorming session culminating in a full-meeting discussion, will foster dialogue between disparate groups that may aid in defining and determining the criteria for follow-on complex drugs and help move U.S. policy forward.
'/>"/>

Contact: Melinda Miller
mmiller@nyas.org
New York Academy of Sciences
Source:Eurekalert

Related biology news :

1. Newly-discovered mechanism can explain the Beckwith-Wiedemann syndrome
2. Newly identified gene powerful predictor of colon cancer metastasis
3. Newly found enzymes may play early role in cancer
4. Obesity starts in the head? 6 newly discovered genes for obesity have a neural effect
5. UC Davis research shows that newly discovered drug reduces heart enlargement
6. Newly described contaminant sources in Katrina-flooded homes pose health risks
7. DNA evidence is in, newly discovered species of fish dubbed H. psychedelica
8. Newly discovered gene plays vital role in cancer
9. Newly discovered epidermal growth factor receptor active in human pancreatic cancers
10. Newly discovered reactions from an old drug may lead to new antibiotics
11. Newly discovered snow roots are evolutionary phenomenon
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... Minn. , Jan. 18, 2017 ... technology company that supports the entire spectrum of ... has been another record-breaking year for the organization ... market interest in MedNet,s eClinical products and services. ... the tremendous marketplace success of iMedNet ...
(Date:1/11/2017)... MOINES, Iowa , Jan. 11, 2017 ... industry first with the release of its patent-pending calibration ... quickly and reliably perform calibrations, securely upload data logs ... flexibility for the customer. "Fighting drunk driving ... only for the public at large, but also for ...
(Date:1/4/2017)...  For the thousands of attendees at this year,s International Consumer Electronics ... and biometric measurement devices and services, will be featuring its new line ... A&D Medical,s special CES Exhibit Suite , the new upper arm ... company,s WellnessConnected product platform.  ... ...
Breaking Biology News(10 mins):
(Date:1/23/2017)... CALGARY , Jan. 23, 2017 /PRNewswire/ - Resverlogix ... preliminary results from the New Zealand ... impaired patients. The data showed remarkable results in reducing ... versus healthy control patients. It is believed that this ... direct connection of this type can be made between ...
(Date:1/23/2017)... ... January 23, 2017 , ... Calvert Labs, Inc. announced today ... Senior Director, Safety Pharmacology. Dr. Thomas earned his M.Sc. and Ph.D. in ... as an academic and industry preclinical drug developer spans more than three decades. ...
(Date:1/23/2017)... ... January 23, 2017 , ... ... the Caribbean Neurosciences Symposium (CANS) annual meeting in Montego Bay, Jamaica from January ... host a hands-on workshop for surgeons to experience the simplicity of the surgical ...
(Date:1/21/2017)... ... January 20, 2017 , ... ... resource to the healthcare industry ( http://www.gandlscientific.com ), has announced the opening of ... of clinical and scientific consultants and contractors. This is the latest step in ...
Breaking Biology Technology: