We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Webinar Recordings » Biosimilars Regulation - Webinar Recording/Transcript

Other Options

Audio Recording/Transcript - Feb. 14, 2019

$287.00

Audio Recording/Transcript - Feb. 14, 2019

$258.00

Audio Recording/Transcript - Feb. 14, 2019

$244.00

Audio Recording/Transcript - Feb. 14, 2019

$230.00

Audio Recording/Transcript - Feb. 14, 2019

$215.00

Biosimilars Regulation - Webinar Recording/Transcript

$287.00
Webinar Recordings

Product Details

Biosimilars Regulation: Latest Regulatory, Compliance & Approval Developments

The FDA is taking steps to more efficiently manage review and licensure pathways to facilitate biosimilar competition. These steps include:

  1. Modernizing policies governing the development of biosimilars to make it more efficient
  2. Educating clinicians, payors and patients about biosimilar products and the rigorous evaluation they must go through
  3. Modernizing regulatory policies to accommodate new scientific tools that better enable comparison between biosimilars and reference products that may reduce the need for clinical studies

In the last two months of 2018 the FDA approved three new biosimilar products. And, in December the FDA released three new guidances and a proposed rule concerning biosimilars.

  • Guidances:
    • Questions and Answers on Biosimilar Development and the BPCI Act  (Dec. 2018)
    • New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2) (Dec. 2018)
    • Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009. (Dec. 2018) 
  • Proposed rule:
    • Definition of the Term “Biological Product” (Dec. 2018)

Nicholas Mitrokostas, partner in the Boston office of Goodwin Procter LLP and Daniel Orr, partner in the Washington, DC office of Womble Bond Dickinson LLP, will provide an overview of the FDA’s current review process, approval standards, and related issues confronting sponsors of reference biologics and biosimilars. Over the course of 90-minutes they’ll discuss:

  • Common problems concerning reference product exclusivity
  • How FDA currently reviews and decides whether to approve a biosimilar application
  • Regulatory and IP considerations and implications of seeking a carve-out of therapeutic indications in the aBLA product label
  • Considerations and implications of using foreign approved products in clinical studies supporting approval of an aBLA, or running clinical trials in foreign countries
  • Insider insight into FDA’s recently proposed rule and recent guidances

This presentation will help you understand current regulatory issues and problems confronting manufacturers of both reference biologics and biosimilars and the relevant intellectual property considerations that could impact regulatory strategy.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing