Tagged as: Alvotech

Alvotech’s E.D. Va. Declaratory Judgment Action Against AbbVie Transferred to N.D. Ill.

On Friday, October 22, 2021, Judge Raymond A. Jackson of the Eastern District of Virginia (E.D. Va.) transferred Alvotech USA and Alvotech hf.’s (jointly, “Alvotech”) declaratory judgment suit against AbbVie Inc. and AbbVie Biotechnology Ltd. (jointly, “AbbVie”) to the Northern District of Illinois (N.D. Ill.) and dismissed AbbVie’s pending motion…

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CHMP adopts positive opinion on Alvotech’s adalimumab biosimilar

European Medicines Agency

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab).  Humira® is approved to treat certain inflammatory conditions.  Róbert Wessman, Founder and Chairman of Alvotech, announced, “We are delighted by the CHMP’s…

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Alvotech Announces Reaching the Primary Completion Date in Its AVT02 Switching Study

On June 15, 2021 Alvotech announced that data collection has been completed from the last of its 568 clinical trial study participants in AVT02-GL-302, a switching study for AVT02, the company’s biosimilar to high concentration (100mg/mL) Humira®. The switching study compared the pharmacokinetics, efficacy, safety, and immunogenicity of AVT02 (40…

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Alvotech Announces Private Placement Financing

Yesterday, Alvotech announced that its parent company, Alvotech Holdings SA, completed a $65 million private placement round, which the company said is part of its $100 million private placement round with a second closing expected shortly.  Alvotech further reported that the $65 million financing resulted in the company issuing new…

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Alvotech and DKSH Extend Partnership in Asia

Alvotech and DKSH recently announced an expansion of their strategic partnership to commercialize six new biosimilar candidates for the Asian markets.  The press release does not name the biosimilar candidates, but states that they “address[] multiple therapeutic areas.”  The companies previously entered into an exclusive license partnership for Alvotech’s adalimumab…

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