Tagged as: Alvotech

Biosimilars Licensing Agreement Updates

Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market.  Pursuant to the agreement, Yoshindo gets exclusive commercialization rights for the biosimilars in Japan, with an estimated market opportunity of $700…

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Biocon and Alvotech Release Statements on FDA Inspections

On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia.  The inspections took place between August 11 and August 30, 2022.  The inspections were triggered by three preapproval inspections…

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Alvotech Begins Confirmatory Study on EYLEA® Biosimilar

Last week Alvotech announced that it has initiated a confirmatory study for its biosimilar candidate to EYLEA®, AVT06 (aflibercept).  EYLEA® is indicated for treating a variety of eye disorders including wet AMD, macular edema, and diabetic retinopathy.  According to Alvotech, the study “is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence…

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Alvotech Debuted on Nasdaq - Big Molecule Watch

Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines announced yesterday that its ordinary shares and warrants will begin trading on Nasdaq today, June 16, under the new ticker symbols “ALVO” and “ALVOW”, respectively.  The debut on Nasdaq follows completion of the company’s business…

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Alvotech Announces Positive Top-Line Results from Clinical Trial for Ustekinumab Biosimilar

On May 24, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a confirmatory clinical trial for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). STELARA® is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Alvotech notes that its trial…

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Alvotech Announces Positive Results from a Pharmacokinetic Similarity Study for Ustekinumab Biosimilar

On May 16, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab).  Alvotech notes that the study used “a single dose, 3-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose…

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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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