Alvotech
NEWS
$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.
After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.
Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.
Following a May 2023 settlement with Amgen, J&J has also signed an agreement with Teva and Alvotech, allowing their Stelara biosimilar to enter the U.S. no later than February 21, 2025.
The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
AbbVie and Alvotech have settled a case, granting Alvotech a non-exclusive license to all Humira-related patents in the United States beginning on July 1, 2023.
Biopharmaceutical firm Alvotech Holdings announced merger plans with Oaktree Acquisition Corp. in a deal that will create a combined entity worth around $2.25 billion.
AbbVie has filed a legal complaint against Icelandic pharmaceutical company Alvotech for the latter’s alleged misappropriation of trade secrets involving the development of a generic version of AbbVie’s rheumatoid arthritis drug Humira.
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