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Teva and Alvotech
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Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Shots:The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…
February 20, 2025

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Alvotech Reports the EMA’s Acceptance of MAA for AVT03 (Biosimilar, Prolia and Xgeva) 

Shots: The EMA has accepted the marketing authorization application of AVT03, a biosimilar version of Prolia & Xgeva (denosumab) Submission was based on the AVT03-GL-C01 trial among postmenopausal women (n=532) with osteoporosis as well as AVT03-GL-P01 (n=209) & AVT03-GL-P03 (n=208) studies among healthy adults, depicting similarity in efficacy, safety, immunogenicity & PK b/w the drugs …
October 10, 2024

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Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio) 

  Shots: Alvotech has begun the confirmatory trial of AVT16, biosimilar version of Entyvio (vedolizumab), that targets alpha-4-beta-7 protein for treating Ulcerative Colitis and Crohn’s disease The P-III (AVT16-GL-C01) trial is a double-blind, two-arm study comparing the efficacy, safety & immunogenicity of AVT16 vs Entyvio in patients of age 18-80yrs. with moderate to severe active…
September 25, 2024

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EMA Accepted the Marketing Application of Alvotech’s AVT06 a Biosimilar of Eylea (aflibercept) 

Shots: Alvotech reported EMA’s acceptance of its marketing application for AVT06, a biosimilar to Eylea used to treat eye disorders, and reported global sales of $5.9B. The company expects its marketing approval in Q3’25 Alvotech will develop and supply the AVT06, while Advanz Pharma will register and have exclusive commercialization rights in Europe except for…
August 15, 2024

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STADA and Alvotech Introduces Uzpruvo (Biosimilar, Stelara) Across the EU

Shots:   The company has introduced Uzpruvo, biosimilar of Stelara (ustekinumab) across the EU to treat gastroenterology, dermatology & rheumatology indications. Uzpruvo is available in a pre-filled syringes with a thinner needle & is latex-free to avoid allergic reactions  Further EU launches are expected in the upcoming mos., pending national price approvals through a fully European supply…
July 22, 2024

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Alvotech & Advanz Pharma
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Alvotech and Advanz Pharma Team Up to Commercialize AVT06/AVT29 (Biosimilar, Eylea) in Europe

  Shots: Alvotech has signed an exclusive partnership agreement with Advanz Pharma to supply and commercialize AVT06 (2mg, Low dose) and AVT29 (8mg, High dose), biosimilars of Eylea As per the agreement, Alvotech will develop & supply the biosimilars and receive an upfront plus subsequent development & commercialization milestones. Advanz Pharma will handle registration &…
June 18, 2024

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Alvotech and STADA Extend their Strategic Partnership Covering AVT03 (Biosimilar, Denosumab) 

Shots: Alvotech & STADA expand their strategic collaboration covering AVT03, biosimilar of Prolia/Xgeva (denosumab), to treat osteoporosis & cancer-related bone loss, respectively As per the agreement, AVT03 will be developed & manufactured by Alvotech at its state-of-the-art facility while STADA becomes marketing authorization holder with semi-exclusive commercial rights across the EU, incl. Switzerland & the…
June 11, 2024

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Insights+ Key Biosimilars Events of May 2024
INSIGHTS+

Insights+ Key Biosimilars Events of May 2024

Shots:   Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency    Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients    During May, Teva & Alvotech launched Simlandi injection Treat Multiple Indications. Our…
June 4, 2024

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News

Alvotech Collaborates with Dr. Reddy’s to Commercialize AVT03 (Biosimilar, Prolia & Xgeva) 

  Shots: Alvotech & Dr. Reddy’s have signed a license & supply agreement to commercialize AVT03 under which Alvotech will handle the development & manufacturing activities. Dr. Reddy will get regulatory & commercial rights exclusively in US and semi-exclusively in the EU & UK  Alvotech will receive an upfront, regulatory & commercial milestones as well as…
May 21, 2024

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