Tagged as: Alvotech

International Biosimilar Approval and Launch Updates

On March 30, 2022, Fresenius Kabi announced that the European Commission approved STIMUFEND, a pegfilgrastim biosimilar referencing NEULASTA, for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy.  STIMUFEND, to launch in a prefilled syringe, is Fresenius’s first approved molecule in its oncology biosimilar portfolio and second biosimilar approved in…

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Alvotech and AbbVie Resolve Disputes Relating to Alvotech’s Adalimumab Biosimilar in Europe

Alvotech Holdings S.A. (“Alvotech”) announced today that it has resolved all intellectual property disputes with AbbVie in Europe related to Alvotech’s AVT02 (adalimumab) biosimilar candidate.  This announcement follows Alvotech’s announcement last month that the company had settled its pending disputes related to AVT02 with AbbVie in the U.S., and states…

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Alvotech and AbbVie Settle Patent Dispute

Alvotech Holdings S.A. (“Alvotech”) has announced that they have settled all pending disputes between AbbVie and Alvotech related to AVT02 (100mg/mL), Alvotech’s high-concentration, citrate-free biosimilar candidate for Humira® (adalimumab). The announcement states that under the settlement agreement, Alvotech has non-exclusive rights to market AVT02 in the United States starting July…

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FDA Accepts Alvotech’s BLA Supporting Interchangeability for ATV02, a High Concentration, Citrate-Free Biosimilar Candidate for Humira®

Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes new data supporting interchangeability between ATV02 and Humira. According to Alvotech’s press release, the data are from a…

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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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