Tagged as: Alexion

Alexion Sues Samsung over Proposed Eculizumab Biosimilar

Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a complaint on January 3, 2024, against Samsung Bioepis Co. Ltd. (“Samsung”) in the U.S. District Court for the District of Delaware, alleging infringement of 6 patents under the BPCIA based on Samsung’s submission of an aBLA for…

Read More

Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 1. STELARA® (ustekinumab) Four months after Janssen Biotech, Inc. settled to terminate Samsung Bioepis Co., Ltd.’s inter partes review (IPR) challenge of U.S….

Read More

Samsung Bioepis Files Four IPR Petitions on Alexion Eculizumab Patents and One IPR Petition on a Janssen Ustekinumab Patent

Samsung recently filed the following IPR petitions challenging all claims of four patents assigned to Alexion relating to SOLIRIS (eculizumab): IPR2023-00998, challenging claims 1-3 of U.S. Patent No. 9,718,880; IPR2023-00999, challenging claims 1-10 of U.S. Patent No. 9,725,504; IPR2023-01069, challenging claims 1-8 of U.S. Patent No. 10,590,189; and IPR2023-01070, challenging…

Read More

EMA Adopts Positive Opinion for Amgen's Eculizumab Biosimilar Candidate BEKEMV®

European Medicines Agency

On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®.  BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant humanized monoclonal IgG2/4κ antibody that binds to the human c5 complement protein.  SOLIRIS® is approved for the treatment of paroxysmal…

Read More

Alexion and Amgen Settle IPRs Over SOLIRIS (eculizumab)

Alexion Pharmaceuticals’ SOLIRIS (eculizumab) is approved in the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PHN), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).  Amgen’s ABP 959 is a biosimilar to SOLIRIS undergoing clinical trials with a phase 3 clinical trial initiated earlier…

Read More