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Fitzpatrick’s BiologicsHQ Monthly Injection – November 2017
April M. Breyer; Corinne E. Atton; Robert S. Schwartz, Ph.D.
December 5, 2017
VIDEO: Reforms at the FDA Level
Ha Kung Wong
November 14, 2017
FCHS Upcoming Events
FCHS Biologics Team
November 7, 2017
Fitzpatrick’s BiologicsHQ Monthly Injection – October 2017
April M. Breyer; Corinne E. Atton; Robert S. Schwartz, Ph.D.
November 3, 2017
Two Bites of The Apple: Five Interesting Facts About Drug Patent IPR Final Written Decisions
Corinne E. Atton; April M. Breyer; Ha Kung Wong
October 23, 2017
Fitzpatrick’s BiologicsHQ Monthly Injection – August/September 2017
April M. Breyer; Corinne E. Atton; Robert S. Schwartz, Ph.D.
October 5, 2017
Pharma at the PTAB
April M. Breyer; Corinne E. Atton; Ha Kung Wong
September 1, 2017
Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto)
Corinne E. Atton; April M. Breyer; Jessica J. Pai; Robert S. Schwartz
August 5, 2017
Fitzpatrick’s BiologicsHQ Monthly Injection – July 2017
April M. Breyer; Corinne E. Atton; Robert S. Schwartz, Ph.D.
July 26, 2017
Drug Patents May Fare Better Than Other Technologies In IPR Proceedings
Corinne E. Atton; April M. Breyer
June 12, 2017
Fitzpatrick’s BiologicsHQ Overview
April M. Breyer; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Brendan M. O'Malley, Ph.D.
June 9, 2017
Supreme Court Hears Oral Argument in Sandoz Inc. v. Amgen Inc.
Brendan M. O'Malley, Ph.D.; Jacob T. Whitt, Ph.D.
April 27, 2017
Federal Circuit Pushes Back on Procedural Issues
Justin J. Oliver; Kathryn Easterling
February 1, 2017
Approval Biosimilar Notice Implicates Millions
Brian L. Klock; Kathryn Easterling
August 3, 2016
180-Day Advance Notice Of First Commercial Marketing Is Mandatory For All Biosimilar Applicants
Robert S. Schwartz, Ph.D.; Corinne E. Atton; Frederick C. Millett; Erica L. Norey
July 7, 2016
Courts Invalidating Life Sciences Discoveries at Alarming Rate Under Mayo/Alice
Frederick C. Millett; Robert S. Schwartz, Ph.D.
June 5, 2016
Coordinating Biosimilar Litigation and Proceedings
Alicia A. Russo
December 12, 2015
The Amgen v. Sandoz BPCIA Decision Stands: the Federal Circuit Denies an En Banc Rehearing
Lawrence S. Perry; H. Rachael Million-Perez
October 22, 2015
Amgen v. Sandoz: Divided Federal Circuit Attempts to Unravel the BPCIA
Alicia A. Russo; Erin J.D. Austin
September 1, 2015
Statistics Show IPRs Favor Patent Challenges
Raymond R. Mandra; Corinne E. Atton
August 25, 2015
3 Ways to Meet Biotech Patent Written Description Standards
Christopher E. Loh; Laura K. Fishwick
June 23, 2015
Federal Circuit Halts Market Launch of the First U.S. Biosimilar
Robert S. Schwartz, Ph.D.; Corinne E. Atton
May 12, 2015
The FDA Approves Zarxio® Opening the Door to the U.S. Biosimilars Market
Robert S. Schwartz, Ph.D.; Corinne E. Atton
March 6, 2015
A Survey of siRNA Nanoscale Delivery Patents
Christopher E. Loh; April M. Breyer
March 24, 2014

METHODOLOGY

Information contained in the Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics Graphics are compiled from information contained in the Fitzpatrick BiologicsHQ database.

DISCLAIMER

BiologicsHQ and materials published on BiologicsHQ are published for informational purposes only. Neither the information nor any opinion expressed on BiologicsHQ constitute legal advice, create an attorney-client relationship, or constitute a solicitation for business. Links or references to third party sites or resources are provided for informational purposes only.

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