Tagged as: Alvotech

Alvotech and BiosanaPharma Enter Exclusive Global Licensing Agreement for AVT23

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….

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International Trade Commission Institutes Investigation of Alvotech’s Adalimumab Biosimilar

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…

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Alvotech and JAMP Pharma Receive Marketing Authorization for SIMLANDI in Canada

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…

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AbbVie Inc. et al. v. Alvotech hf. Updates

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…

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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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