On August 2, 2022, Coherus BioSciences announced that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all five indications, meeting the FDA’s rigorous standards to the reference product, including safety, efficacy, and quality. Coherus plans to launch CIMERLI™ in early October 2022.
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Final Judgment Entered in Amgen v. Coherus Neulasta Litigation
Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent infringement case brought by Amgen Inc. and Amgen Manufacturing, Limited (collectively “Amgen”) against Coherus Biosciences, Inc. (“Coherus”). Judge Stark previously issued a Memorandum Order on March 26, 2018, adopting Magistrate Judge Burke’s Report…
Humira®’s Wall of Patents Continues to Come Under Attack
On November 6, 2017, Sandoz, Inc. filed its eighth inter partes review (“IPR”) against AbbVie Biotechnology Ltd. (“AbbVie”), challenging yet another patent from the Humira® patent portfolio. Humira®, used for the treatment of autoimmune diseases such as rheumatoid arthritis and Crohn’s disease, continues to be the number one selling drug in the world.[i] With…
Boehringer Ingelheim Prevails in IPR Against AbbVie’s ’135 Humira Patent
Boehringer Ingelheim International GMBH and Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) have prevailed in two inter parts review trials against one of AbbVie’s patents related to Humira®. In two final written decisions issued, the Patent Trial and Appeal Board (the “PTAB” or “Board”) found all claims of U.S. Patent No. 8,889,135 (the ’135 patent”) invalid.…
Coherus Files Four IPR Petitions on Humira® Patent
Coherus Biosciences, Inc. (“Coherus”) has filed four petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of U.S. Patent No. 9,085,619 (“the ’619 patent”) related to AbbVie’s Humira® (adalimumab). The challenged claims of the ’619 patent are directed to formulations of adalimumab and closely-related antibodies. Adalimumab is a TNF…