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

  • 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
  • Enbrel Biosimilar Approved in US But Enjoined For Now On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions.  The biosimilar, Erelzi (etanercept-szzs), is the third biosimilar approved for marketing in the US under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  Erelzi has been approved for all of Enbrel’s indications and is the first U.S. biosimilar of etanercept.  In its announcement FDA noted that “Erelzi has... More
  • The Ripple Effect of the Federal Circuit’s Decision in Amgen v. Apotex on Biosimilar Litigation In July, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed, Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009 (BPCIA).  The Federal Circuit affirmed the district court’s preliminary injunction barring Apotex from selling its proposed biosimilar until 180 days after post-licensure notice of first commercial marketing.  The Federal Circuit held that 180 days’ notice was mandatory regardless of whether the biosimilar maker provided its regulatory... More
  • Judge Dismisses Amgen’s BPCIA Declaratory Judgment Action Against Sandoz Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (“BPCIA”).  Amgen and Sandoz are involved in a web of biosimilar litigation regarding Sandoz’s proposed biosimilar versions of Amgen’s related drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim).  In March of this year, Amgen filed a lawsuit seeking a declaratory judgment that Sandoz violated the BPCIA by attempting... More