FDAnews Announces -- Biosimilars Regulation: Latest Regulatory, Compliance & Approval Developments Webinar, Feb. 14, 2019

FDA is taking steps to efficiently manage biosimilars review and licensure pathways to facilitate competition. Find out the latest here…

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FDANEWS

Feb 04, 2019, 17:00 ET

FALLS CHURCH, Va., Feb. 04, 2019 /PRNewswire-PRWeb/ -- Biosimilars Regulation
Latest Regulatory, Compliance & Approval Developments
**An FDAnews Webinar**
Thursday, Feb. 14, 2019, 1:30 p.m. - 3:00 p.m.EST
http://www.fdanews.com/biosimilarsreg

Biologics account almost 40% of all prescription drug spending — and that percentage is growing.

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.

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 attendees 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.

Meet Your Presenters:
Nicholas Mitrokostas is a Partner in the Boston office of Goodwin Procter LLP. He has extensive trial and PTAB experience representing clients in the pharmaceutical and biotechnology industries in patent and antitrust litigation and counseling those clients with regard to their intellectual property and regulatory strategies. He has a wide-ranging pharmaceutical practice representing both innovator and challenger entities, including filers of 501(b)(1), 505(b)(2), 505(j) and aBLAs. He is the lead editor of the firm's Biosimilars Reference Guide and the biosimilars blog, http://www.bigmoleculewatch.com, which provides resources, information and analysis on biologics, biosimilars and the Biologics Price Competition and Innovation Act (BPCIA).

Daniel Orr is a Partner in the Washington, DC office of Womble Bond Dickinson LLP and represents originator biopharmaceutical clients in FDA regulatory matters. He previously served as a Regulatory Counsel with the U.S. Food & Drug Administration where he advised the agency concerning a portfolio of products with combined annual sales of more than $37 billion, including review and approval of three biosimilars. While at the FDA, Dan chaired the agency's working group for the proposed rule "Definition of the Term 'Biological Product" as well as serving on the agency's Exclusivity Board for drugs and biologics.    

Who Will Benefit:

  • Executive suite
  • Strategic planners
  • Regulatory affairs
  • R&D
  • Marketing/sales
  • Legal counsel

Webinar Details:
Biosimilars Regulation
Latest Regulatory, Compliance & Approval Developments
**An FDAnews Webinar**
Thursday, Feb. 14, 2019, 1:30 p.m. - 3:00 p.m.EST
http://www.fdanews.com/ biosimilarsreg

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/biosimilarsreg
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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