On March 8, 2022, Alvotech announced that it has executed a U.S. settlement agreement with Abbvie that grants Alvotech non-exclusive rights to market AVT02 (adalimumab) in the U.S starting July 1, 2023. AbbVie confirmed the resolution of disputes and stated that Alvotech will take a non-exclusive license to the patents, and in return, pay royalties
Last week, Coherus BioSciences, Inc. (“Coherus”) announced that the United States Food and Drug Administration (“FDA”) approved YUSIMRY™, an adalimumab biosimilar. YUSIMRY™ is a tumor necrosis factor blocker approved as a subcutaneous formulation. It is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. This is
During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20 billion in 2020. While none have launched thus far, at least eight adalimumab biosimilars are due to launch by
A white paper released in 2019 by The Biosimilars Forum and Medicines for Europe shows the United States and Europe accounting for more than a combined 80% of sales of biologic medicines, and more than a combined 90% of biosimilars.[1] This, of course, has led to a focus on these markets for the biopharmaceutical
RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar products.
The Patent Trial and Appeal Board (“PTAB”) recently denied Sandoz’s petition for inter partes review (“IPR”) of claims 1-30 of AbbVie’s patent, U.S. Patent No. 9,187,559 (“the ’559 patent”). The ’559 patent is directed towards a multiple-variable dose regimen for treating idiopathic inflammatory bowel disease. The patent discloses administering a high dose of a TNFα
Fujifilm Kyowa Kirin Biologics Co., Ltd. (“Fujifilm”) recently announced that it will partner with Mylan N.V. (“Mylan”) to commercialize a biosimilar to adalimumab developed by Fujifilm. Under the terms of the agreement, Fujifilm grants Mylan an exclusive license to commercialize the biosimilar in Europe, and will receive an up-front fee in return. In addition, Fujifilm
On the same day that the PTAB instituted review of an AbbVie Biotechnology Ltd. (“AbbVie”) patent covering a method of using adalimumab to treat psoriatic arthritis, it also instituted review of a second AbbVie patent directed to the use of adalimumab to treat chronic plaque psoriasis. More specifically, and once again at the urging of
At the urging of Sandoz Inc. (“Sandoz”), the PTAB instituted review of claims 1, 2, and 5-7 of U.S. Patent No. 9,067,992 (“the ʼ992 patent”) on April 3, 2018. The ʼ992 patent is entitled “Use of TNFα Inhibitor for Treatment of Psoriatic Arthritis,” and is assigned to AbbVie Biotechnology Ltd. (“AbbVie”). The claims of the
Last week, the Federal Circuit affirmed a lower court’s dismissal of AbbVie’s complaint seeking declaratory judgment of invalidity of U.S. Patent No. 6,248,516 (“the ’516 patent”) owned by Astra Zeneca subsidiary MedImmune. AbbVie brought this declaratory judgment action in June 2016 in the hopes of ending its royalty obligations to MedImmune.
The Fed. Circuit’s decision