Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s Humira® (adalimumab) rocketed to the best-selling drug in the world with sales generating over $16 billion USD in 2016. The top biologic drugs are all driving revenues well beyond the $1 billion sales revenue demarcation that
Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States District Court for the District of Delaware against Boehringer Ingelheim International GMBH, Boehringer Ingelheim Pharmaceuticals, Inc., and Boehringer Ingelheim Fremont, Inc. (collectively “Boehringer Ingelheim” or “Defendant”) related to Boehringer Ingelheim’s adalimumab product, a proposed biosimilar to AbbVie’s
Sandoz, Inc. (“Sandoz”) entered into the battlefield over patents related to AbbVie’s Humira® (adalimumab). On July 20, 2017, Sandoz filed petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of two patents assigned to AbbVie, U.S. Patent No. 8,802,100 (“the ’100 patent”) entitled “Formulation of Human Antibodies for Treating TNF-Alpha
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.
On June 22, 2017, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicine’s Agency (“EMA”) recommended Samsung Bioepis’ Imraldi® (SB-5, adalimumab), a biosimilar to AbbVie’s Humira®, for approval. The CHMP’s recommendation will be referred to the European Commission for final marketing authorization.
Adalimumab is a TNF (tumor necrosis factor) inhibitor
Fujifilm Kyowa Kirin Biologics announced that its Medical Marketing Application (“MMA”) for FKB327, a biosimilar to AbbVie’s Humira® (adalimumab), has been accepted for review by the European Medicines Agency (“EMA”). Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated
Amgen’s Amgevita, an adalimumab biosimilar to AbbVie’s Humira®, received approval from the European Commission on March 23, 2017. Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α) preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases.
Amgevita received approval in all available indications, including the
Samsung Bioepsis UK Limited (“Samsung”), Biogen Idec Limited (“Biogen”), and Fujifilm Kyowa Kirin Biologic Company Limited (“Fujifilm Biologics”) have prevailed against two of AbbVie’s patents for Humira® in the UK.
On March 3, 2017, Justice Henry Carr of the UK High Court of Justice issued a decision declaring that administration of 40mg of adalimumab once
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