Biologics Blog

Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry.

Recent Blog Posts

  • U.S. Biosimilars Pathway Under Trump This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception.  Two of Trump’s stated policies might bear directly on how biologics will be protected and litigated in this country and abroad: the repeal of the Affordable Care Act of 2010 (ACA), also known as Obamacare, and the repudiation of the Trans-Pacific Partnership (TPP). The Biologics Price Competition and Innovation Act (BPCIA) was... More
  • FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept any filing or approve any application for a biosimilar version of Humira® (adalimubab), AbbVie’s best-selling biologic, or any other product for which a biologics license application (BLA) was submitted to FDA prior to March 23, 2010, the date on which the Biologics... More
  • Biosimilar Litigation Update With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are seven ongoing biosimilar litigations in the U.S.  Here are brief updates on recent developments in these cases. AbbVie v. Amgen (Humira/adulimimab) The litigation between AbbVie and Amgen over Humira, the world’s best-selling biologic, is still in its early stages, with AbbVie having filed suit in August asserting infringement of ten patents selected for the BPCIA’s immediate litigation phase.   Amgen’s application... More
  • Humira Biosimilar Approved As Litigation Gets Going The FDA on Friday approved the first U.S. biosimilar of Humira (adalimumab), AbbVie’s best-selling biologic for treatment of inflammatory conditions.  The biosimilar, Amgen’s Amjevita (adalimumab-atto), received approval for all of the indications requested by Amgen:  in adults, moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, and moderate to severe plaque psoriasis, and in patients four years of age and older, moderately to severely active polyarticular... More
  • Apotex Prevails in Neulasta Biosimilar Litigation, Files for Cert on 180-Day Issue Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim).  That dispute has resulted in the first final judgment in a BPCIA lawsuit.  Earlier this month, Judge James Cohn of the Southern District of Florida ruled after a consolidated bench trial addressing both products that Apotex’s biosimilar applications did not infringe Amgen’s sole remaining patent,... More
  • Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent It has been four years since the first inter partes review proceedings were filed in the United States.  The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the Supreme Court, and the number of IPR filings has greatly exceeded expectations, making the Patent Trial and Appeal Board one of the most important and busiest forums for patent validity litigation in the US.  IPRs were intended to help high-tech... More
  • Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction.  The appeal presents an important question for biosimilar litigation:  where biosimilar applicants fail to provide manufacturing information in the pre-litigation information exchanges of the Biologics Price Competition and Innovation Act (BPCIA), are they required to provide that information in litigation even if it is irrelevant to the asserted patents?  The question is particularly important... More
  • CIMZIA Does Not Infringe Yeda’s Monoclonal Antibody Patent In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s  Cimzia® (certolizumab pegol), a biologic medicine that treats inflammatory conditions such as rheumatoid arthritis and Crohn’s disease, does not infringe a monoclonal antibody patent owned by Yeda Research and Development Co., Ltd..  (Fed. Cir. Appeal No. 2015-1957, September 8, 2016).  UCB sued Yeda requesting a declaration that Cimzia did not infringe Yeda’s patent. ... More
  • Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that biosimilar makers could opt out of the first step of the BPCIA pre-litigation procedures, the provision requiring biosimilar makers to provide their abbreviated Biologics License Application (aBLA) and other manufacturing information describing the processes used to make the biosimilar twenty days after the FDA accepts the... More
  • US Biosimilar Pathway Update Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US.  Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved.  Zarxio, a relatively simple biologic, was approved in March 2015 under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  Zarxio has now has been on the market for a year (since September 2015).  This year, FDA approved two complex biologics, Celltrion and Pfizer’s Inflectra,... More