Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Peptimmune Files Citizen Petition Regarding Generic Copaxone and Demonstrates Significant Enabling Technology for Biological Characterization of Copaxone

October 4, 2010 By Bio-Medicine.Org

SOMERVILLE, Mass., Oct. 4 /PRNewswire/ — Peptimmune, Inc.
announced today that it has filed a technically focused Citizen
Petition requesting that the FDA not approve any application for a
generic version of Copaxone® [glatiramer acetate injection] (Teva Pharmaceuticals).

“We feel that it is important for the FDA to have access to
Peptimmune’s data resulting from our characterization of Copaxone
using proprietary methods when considering ANDA applications for
generic forms of glatiramer acetate.  We believe that
manufacturers of any purported generic version of Copaxone need to
demonstrate biological equivalence using state of the art methods.
 Most importantly, this extensive biological characterization
that we have developed can serve to further guarantee the safety in
multiple sclerosis patients of any purported generic version of
Copaxone,” stated Thomas P. Mathers, President and Chief Executive
Officer of Peptimmune.

The Citizen Petition provides data that highlights several key
points for the FDA’s consideration:

  1. Comparative pharmacokinetic (PK) studies with a state of
    the art method should be required to demonstrate bioequivalence of
    a purported generic Copaxone
  2. The demonstrated bioavailability of Copaxone is linearly
    correlated to its direct effect on the innate immune
    system
  3. Pharmacodynamic (PD) studies with state of the art
    methods are just as important as PK studies due to Copaxone’s
    potent effect on the innate immune system
  4. Copaxone is a pro-drug which makes the demonstration of
    bioequivalence very difficult for a purported generic
    copy

Eric H. Zanelli, PhD, Vice President of Research and Development
remarked that, “The safety and efficacy of any proposed generic
copy of such a complex drug cannot be guaranteed by physicochemical
characterization only.  Demonstration of bioequivalen

‘/>”/>

SOURCE

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech