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Fitzpatrick’s BiologicsHQ Monthly Injection – September 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
October 6, 2018  READ MORE
FCHS Upcoming Events
FCHS Biologics Team
September 19, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – August 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
September 6, 2018  READ MORE
Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs)
April M. Breyer Menon; Joseph K. Yarsky; Corinne E. Atton; Robert S. Schwartz, Ph.D.
August 31, 2018  READ MORE
Spotlight On: Rituxan® (rituximab)
April M. Breyer Menon; Corinne E. Atton; Joyce L. Nadipuram; Robert S. Schwartz, Ph.D.
August 31, 2018  READ MORE
Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm)
April M. Breyer Menon; Corinne E. Atton; Joseph K. Yarsky; Robert S. Schwartz, Ph.D.
August 31, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – July 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
August 3, 2018  READ MORE
Trends And Predictions For Serial Biologic Drug IPR Petitions
Frederick C. Millett; Robert S. Schwartz, Ph.D.
July 31, 2018  READ MORE
Biosimilars and the Biologics Price Competition and Innovation Act (BPCIA)
Michael Enzo Furrow, Ph.D.; Whitney L. Meier
July 31, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – June 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
July 6, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – May 2018
April M. Breyer Menon; Joseph K. Yarsky; Corinne E. Atton; Robert S. Schwartz, Ph.D.
June 8, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – April 2018
April M. Breyer Menon; Corinne E. Atton; Joseph K. Yarsky; Robert S. Schwartz, Ph.D.
May 3, 2018  READ MORE
IPR Patentability of All Challenged Claims – SAS Institute v. Iancu
Douglas Sharrott; Shannon K. Clark
April 24, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – March 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
April 6, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – February 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
March 6, 2018  READ MORE
WEBINAR: Update on Biologic Drug IPRs: Lessons Learned
Corinne E. Atton; Whitney L. Meier; Robert S. Schwartz, Ph.D.
February 22, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – January 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
February 7, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – December 2017
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
January 8, 2018  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – November 2017
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
December 5, 2017  READ MORE
VIDEO: Reforms at the FDA Level
Ha Kung Wong
November 14, 2017  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – October 2017
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
November 3, 2017  READ MORE
Two Bites of The Apple: Five Interesting Facts About Drug Patent IPR Final Written Decisions
Corinne E. Atton; April M. Breyer Menon; Ha Kung Wong
October 23, 2017  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – August/September 2017
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
October 5, 2017  READ MORE
Pharma at the PTAB
April M. Breyer Menon; Corinne E. Atton; Ha Kung Wong
September 1, 2017  READ MORE
Fitzpatrick’s BiologicsHQ Monthly Injection – July 2017
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
July 26, 2017  READ MORE
Drug Patents May Fare Better Than Other Technologies In IPR Proceedings
Corinne E. Atton; April M. Breyer Menon
June 12, 2017  READ MORE
Fitzpatrick’s BiologicsHQ Overview
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Brendan M. O'Malley, Ph.D.
June 9, 2017  READ MORE
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  READ MORE
Federal Circuit Pushes Back on Procedural Issues
Justin J. Oliver; Kathryn Easterling
February 1, 2017  READ MORE
Approval Biosimilar Notice Implicates Millions
Brian L. Klock; Kathryn Easterling
August 3, 2016  READ MORE
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  READ MORE
Courts Invalidating Life Sciences Discoveries at Alarming Rate Under Mayo/Alice
Frederick C. Millett; Robert S. Schwartz, Ph.D.
June 5, 2016  READ MORE
Amgen v. Sandoz: Divided Federal Circuit Attempts to Unravel the BPCIA
Alicia A. Russo; Erin J.D. Austin
September 1, 2015  READ MORE
Statistics Show IPRs Favor Patent Challenges
Raymond R. Mandra; Corinne E. Atton
August 25, 2015  READ MORE
3 Ways to Meet Biotech Patent Written Description Standards
Christopher E. Loh; Laura K. Fishwick
June 23, 2015  READ MORE
Federal Circuit Halts Market Launch of the First U.S. Biosimilar
Robert S. Schwartz, Ph.D.; Corinne E. Atton
May 12, 2015  READ MORE
The FDA Approves Zarxio® Opening the Door to the U.S. Biosimilars Market
Robert S. Schwartz, Ph.D.; Corinne E. Atton
March 6, 2015  READ MORE
A Survey of siRNA Nanoscale Delivery Patents
Christopher E. Loh; April M. Breyer Menon
March 24, 2014  READ MORE

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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