On September 27, 2022, Judge Richard Andrews of the District of Delaware granted Novartis’s motion to dismiss declaratory judgment (“DJ”) counterclaims raised by two generic drug manufacturers in the ongoing litigation regarding Novartis’s heart failure medication, Entresto® (sacubitril/valsartan).[1] The decision provides guidance to ANDA applicants seeking to maintain a case or controversy for DJ

On September 9, 2022, Biogen Inc. and Biogen MA Inc. (“Plaintiffs”) filed suit against Sandoz Inc., Sandoz International GMBH, Sandoz GMBH, and Polpharma Biologics S.A. (collectively, “Defendants”) in the District of Delaware concerning twenty-eight different patents. Although the complaint was filed under seal, the complaint appears to be related to Defendants’ natalizumab biosimilar (proprietary name

  • FDA and EMA both approve additional biosimilar versions of Humira® (adalimumab).
  • FDA also approves its third biosimilar version of Neupogen® (filgrastim).
  • EMA has not approved any new biosimilars in 2022, but has recommended approval of teriparatide biosimilar Sondelbay and the pegfilgrastim biosimilar Stimufend.

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a

Updated November 15, 2021

  • FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab).
  • FDA has approved only two biosimilars in 2021 after only approving three in 2020.
  • EMA approves four more Avastin® (bevacizumab) biosimilars, bringing the total number of approved bevacizumab approvals to nine, but also withdraws approval of two of bevacizumab and

On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira® (adalimumab).  We previously discussed Boehringer Ingelheim’s Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”).  The

The recently enacted “Purple Book Continuity Act of 2019” went into effect as of June 25, 2021.  The FDA must proactively update the Purple Book information every 30 days with an alphabetical list of licensed biologics, including the date of marketing application approval and the marketing/licensure status.  Additionally, there is now a potentially higher price

Updated March 8, 2021

  • FDA has not approved any biosimilars in 2021 after only approving three in 2020.
  • EMA approves second Novolog® (insulin aspartate), fifth Avastin® (bevacizumab), eighth Neulasta® (pegfilgrastim), and twelfth Humira® (adalimumab) biosimilars, and withdraws approval of an adalimumab biosimilar and a pegfilgrastim biosimilar.
  • Given the increasing number of approved biosimilars in Europe,

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”).  The Citizen Petition is available on regulations.gov under docket number: FDA-2020-P-2247.  Boehringer Ingelheim seeks an interpretation of “strength” to

In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent infringement cases.  Section 1400(b) provides that an action for patent infringement may be brought in the judicial district where the

Updated October 12, 2020

  • FDA has only approved two biosimilars in 2020.
  • No biosimilars have launched in the U.S. since April 2020.
  • EMA approves first Novolog® (insulin aspartate), third and fourth Avastin® (bevacizumab), and sixth Herceptin® (trastuzumab) biosimilars.

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs