Alvotech Holdings S.A. (“Alvotech”) announced that it has entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23 (also called BP001), a proposed biosimilar to Xolair® (omalizumab). Xolair® is an anti-IgE antibody indicated for treating certain patients with either moderate to severe persistent asthma or chronic idiopathic urticaria….
On January 28, 2022, the Food and Drug Administration (FDA) approved Genentech’s VABYSMO (faricimab-svoa) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). According to the Genentech press release, VABYSMO targets and neutralizes angiopoietin-2 (ang-2) and vascular endothelial growth factor-A (VEGF-A). The press release also…
As noted in our December 21, 2021 post, Complainants AbbVie Inc., AbbVie Biotechnology Ltd. and AbbVie Operations Singapore Pte. Ltd. filed a complaint at the International Trade Commission against Respondents Alvotech hf., Alvotech Germany GmbH, Alvotech Swiss AG, Alvotech USA Inc., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA Inc., and…
Last week, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics for an aggregate consideration of up to $2.3 billion. According to a press release from Samsung Biologics, Biogen initially invested a 15% stake when the…
Lannett Company, Inc. (“Lannett”) announced Friday that the FDA has completed its safety review of Lannett’s Investigational New Drug application for Lannett’s insulin glargine biosimilar, a product Lannett is co-developing with its strategic alliance partners within the HEC group of companies, and has concluded that the company may proceed with…
On January 12, the International Generic and Biosimilar Medicines Association (IGBA) announced that Vivian Fritelli, Chief Executive of Generic and Biosimilar Medicines of Southern Africa, will be the next IGBA Chair for 2022. The IGBA represents manufacturers of generic and biosimilars medicines around the world, and “works to improve patients’…
On January 10, 2022, Alvotech Holdings S.A. (“Alvotech”) and JAMP Pharma Group (“JAMP Pharma”) announced that Health Canada granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab) developed by Alvotech. The biosimilar, also referred to as AVT02, will be marketed in Canada as SIMLANDI (100 mg/mL…
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the second wave suit, on December 21, 2021, AbbVie filed a Second Amended Complaint. On December 29, Alvotech filed a Renewed Motion to Dismiss…
Last week, Samsung Bioepis Co., Ltd. and Organon & Co. announced that the FDA accepted for review their supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar referencing HUMIRA (adalimumab). The FDA previously approved SB5 under the brand name HADLIMA as a low-concentration…
Last week, the PTAB instituted inter partes review of two Chugai patents directed to methods of treating rheumatoid arthritis with a combination of tocilizumab and methotrexate. Fresenius filed petitions for inter partes review on U.S. Patent Nos. 7,521,052 (“the ’052 patent”) and 10,744,201 (“the ’201 patent”) on June 28, 2021. …