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News

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg)
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
October 31, 2024  READ MORE
Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro)
April Breyer Menon; Joseph K. Yarsky; Corinne E. Atton; Robert S. Schwartz, Ph.D.
October 31, 2024  READ MORE
Spotlight On: Biosimilar Litigations
April Breyer Menon; Ha Kung Wong
October 31, 2024  READ MORE
Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx)
April Breyer Menon; Corinne E. Atton; Joyce L. Nadipuram; Robert S. Schwartz, Ph.D.
October 31, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – September 2024
Damineh Morsali, Ph.D.; Monica Chou; Robert S. Schwartz, Ph.D.
October 11, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – July 2024
Monica Chou; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
August 10, 2024  READ MORE
Genzyme Files Complaint Against Sarepta Concerning Gene Therapy Elevidys®
Monica Chou; Robert S. Schwartz, Ph.D.
August 8, 2024  READ MORE
Implications of Loper Bright for FDA-Regulated Products
Todd Harrison; Claudia Lewis; Justin Coen; Jeremiah Kelly
July 10, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – June 2024
Monica Chou; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
July 9, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – May 2024
Damineh Morsali, Ph.D.; Monica Chou; Robert S. Schwartz, Ph.D.
June 11, 2024  READ MORE
The First Biosimilar Disputes at the Unified Patent Court (UPC)
Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
May 22, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – April 2024
Monica Chou; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
May 16, 2024  READ MORE
PTAB Proposes Rules Governing Director Review of PTAB Decisions
Monica Chou; Robert S. Schwartz, Ph.D.
May 3, 2024  READ MORE
Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation
Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
April 30, 2024  READ MORE
PTAB Issues Final Written Decisions On Zynteglo® Gene Therapy Patents
Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
April 25, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – March 2024
Monica Chou; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
April 10, 2024  READ MORE
EYLEA® IPR Appeals Filed
Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
March 21, 2024  READ MORE
The First Prolia® / Xgeva® Biosimilar Approvals in the U.S.
Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
March 15, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – February 2024
Damineh Morsali, Ph.D.; Monica Chou; Robert S. Schwartz, Ph.D.
March 13, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – January 2024
Monica Chou; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
February 13, 2024  READ MORE
Accord’s aBLA for Proposed Biosimilar DMB-3115 Accepted by FDA
Monica Chou; Robert S. Schwartz
January 24, 2024  READ MORE
Venable’s BiologicsHQ Monthly Injection – December 2023
Damineh Morsali, Ph.D.; Monica Chou; Robert S. Schwartz, Ph.D.
January 13, 2024  READ MORE
EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates
Robert S. Schwartz; Monica Chou; Damineh Morsali, Ph.D.
December 31, 2023  READ MORE
EYLEA® (aflibercept) IPR and BPCIA Litigation Updates
Damineh Morsali, Ph.D.; Robert S. Schwartz
December 15, 2023  READ MORE
BPCIA Complaint Against Proposed Rituxan® Biosimilar DRL_RI Filed
Monica Chou; Robert S. Schwartz, Ph.D.
December 13, 2023  READ MORE
BPCIA Litigation Related to Proposed Eylea Biosimilar CT-P42 Filed
Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
November 22, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – September 2023
Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
October 16, 2023  READ MORE
Complimentary Life Sciences Webinar Series
Venable Speakers
October 6, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – August 2023
Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
September 12, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – July 2023
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
August 15, 2023  READ MORE
PREVAIL Act Reforms at the PTAB
Damineh Morsali, Ph.D.; Ha Kung Wong
August 14, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – June 2023
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
July 15, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – May 2023
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
June 13, 2023  READ MORE
Supreme Court Affirms Lack of Enablement in Amgen v. Sanofi Antibody Patent Dispute
Kaitlyn M. Rodnick; Ha Kung Wong; Megan S. Woodworth
May 18, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – April 2023
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
May 8, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – March 2023
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
April 10, 2023  READ MORE
The State of Biosimilars in 2023
April Breyer Menon; Ha Kung Wong
March 17, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – February 2023
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
March 15, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – January 2023
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
February 9, 2023  READ MORE
First Humira Biosimilar Enters the U.S. Market
April Breyer Menon; Ha Kung Wong
February 3, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – December 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
January 12, 2023  READ MORE
Venable’s BiologicsHQ Monthly Injection – November 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
December 14, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – October 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
November 14, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – September 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
October 11, 2022  READ MORE
Biosimilars Approved in the EU are Considered Interchangeable
April Breyer Menon; Ha Kung Wong
September 30, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – August 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
September 8, 2022  READ MORE
First Interchangeable FDA Approval without a Switching Study
April Breyer Menon; Ha Kung Wong
August 31, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – July 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
August 5, 2022  READ MORE
The Trouble With IP for Digital Health and Precision Medicine
Ha Kung Wong; April Breyer Menon
July 19, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – June 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
July 8, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – May 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
June 7, 2022  READ MORE
PTAB Director Review Updates
April Breyer Menon
May 29, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – April 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
May 9, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – March 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
April 18, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – February 2022
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
March 8, 2022  READ MORE
A Survey of PGR Outcomes
April Breyer Menon; Robert S. Schwartz, Ph.D.
February 28, 2022  READ MORE
What does USPTO director review really change?
April Breyer Menon; Ha Kung Wong
February 18, 2022  READ MORE
Venable’s BiologicsHQ Monthly Injection – October 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
November 10, 2021  READ MORE
U.S. Patent Legal Landscape Outlook
Ha Kung Wong
October 22, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – September 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
October 12, 2021  READ MORE
2021 Patent Caselaw Roundup – Lawline CLE
Christopher Loh
October 11, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – August 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.
September 8, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – July 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
August 11, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – June 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
July 13, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – May 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
June 17, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – April 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
May 12, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – March 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
April 7, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – February 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
March 9, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – January 2021
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
February 8, 2021  READ MORE
Venable’s BiologicsHQ Monthly Injection – December 2020
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
January 12, 2021  READ MORE
Patent Cases To Watch In 2021
Ha Kung Wong
January 3, 2021  READ MORE
The Leading “Not So Different” Podcast Episodes of 2020
Ha Kung Wong; April Breyer Menon
December 30, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – November 2020
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
December 9, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – October 2020
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
November 9, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – September 2020
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
October 8, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – August 2020
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
September 9, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – July 2020
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
August 10, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – June 2020
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
July 9, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – May 2020
April Breyer Menon; Damineh Morsali, Ph.D.; Robert S. Schwartz, Ph.D.; Ha Kung Wong
June 8, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – April 2020
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong
May 6, 2020  READ MORE
Commentary: A Competitive Marketplace for Biosimilars
April Breyer Menon; Ha Kung Wong
May 5, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – March 2020
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong
April 8, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – February 2020
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong
March 12, 2020  READ MORE
FDA Updates Relating to Biosimilars
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong
February 29, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – January 2020
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong
February 6, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – December 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong
January 7, 2020  READ MORE
Venable’s BiologicsHQ Monthly Injection – November 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
December 9, 2019  READ MORE
Seven Years of Orange Book Patent IPRs: Where Are We Now?
Corinne E. Atton; April Breyer Menon
November 22, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – October 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong
November 11, 2019  READ MORE
Will Authorized Biologics Disrupt The Market For Biosimilars?
Ha Kung Wong; Erica L. Norey
November 5, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – September 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
October 8, 2019  READ MORE
Can Congress Speed Biosimilars to Market by Limiting Patent Litigations?
Ha Kung Wong; April Breyer Menon
September 30, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – August 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
September 9, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – July 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
August 6, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – June 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
July 9, 2019  READ MORE
Will Product Drift Cause a Rift?
Ha Kung Wong
July 1, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – May 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
June 6, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – April 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
May 7, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – March 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
April 5, 2019  READ MORE
Biosimilars And The BPCIA: Past, Present, And Future
Ha Kung Wong; April M. Breyer Menon
March 19, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – February 2019
April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
March 6, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – January 2019
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
February 11, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – December 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
January 9, 2019  READ MORE
Venable’s BiologicsHQ Monthly Injection – November 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
December 11, 2018  READ MORE
Venable’s BiologicsHQ Monthly Injection – October 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
November 12, 2018  READ MORE
Fitzpatrick, Cella, Harper & Scinto Officially Joins Venable
Venable Fitzpatrick Press Release
November 1, 2018  READ MORE
Venable’s BiologicsHQ Monthly Injection – September 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
October 6, 2018  READ MORE
Venable’s BiologicsHQ Monthly Injection – August 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
September 6, 2018  READ MORE
Venable’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
Venable’s BiologicsHQ Monthly Injection – June 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
July 6, 2018  READ MORE
Venable’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
Venable’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
Venable’s BiologicsHQ Monthly Injection – March 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
April 6, 2018  READ MORE
Venable’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
Venable’s BiologicsHQ Monthly Injection – January 2018
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
February 7, 2018  READ MORE
Venable’s BiologicsHQ Monthly Injection – December 2017
April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.
January 8, 2018  READ MORE
Venable’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
Venable’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
Venable’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
Venable’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
Venable’s BiologicsHQ Overview
April 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 Venable 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 Venable BiologicsHQ database.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

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