Tagged as: Alvotech

Alvotech and Advanz Pharma Extend Partnership to Commercialize Five Proposed Biosimilars in Europe

Advanz Pharma (“Advanz”) and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development and commercial supply of the biosimilars, and Advanz responsible for registration and commercialization in Europe.  Per the announcement, the agreement includes proposed…

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Biosimilar Clinical Trial Updates

On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab).  The clinical study will compare the efficacy, safety, and immunogenicity of AVT05 and Simponi in adult patients with moderate to severe rheumatoid arthritis.  Per the announcement,…

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Alvotech and Bioventure Announce Approval of ADALIMUMAB Biosimilar in Saudi Arabia

On January 24, Alvotech and Bioventure, a subsidiary of GlobalOne Healthcare Holding LLC, announced that the Saudi Food & Drug Authority has approved SIMLANDI, a biosimilar referencing HUMIRA (adalimumab), in Saudi Arabia. According to the press release, Bioventure is Alvotech’s exclusive strategic partner for the commercialization of SIMLANDI in the…

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Alvotech and Teva Announce Acceptance of BLA for AVT04, a Proposed Biosimilar to STELARA (ustekinumab)

On Jan 6, 2023, Alvotech and Teva announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab), and stated that the companies anticipate that the FDA’s review will be completed in the second half of 2023. In August 2020,…

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Alvotech Initiates Study of Biosimilar of J&J's Rheumatoid Arthritis Drug SIMPONI

Alvotech announced yesterday the initiation of a pharmacokinetic study for AVT05, a biosimilar referencing Johnson & Johnson’s (“J&J”) SIMPONI and SIMPONI ARIA (golimumab).  SIMPONI is used to treat certain types of rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and ulcerative colitis (UC). The study will assess…

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Alvotech Broadens Access to HUMIRA (adalimumab) Biosimilars

Alvotech announced yesterday the launch of HUKYNDRA, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab), in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia.  Through a strategic partnership with STADA, Alvotech supplies HUKYNDRA (adalimumab) autoinjectors and pre-filled syringes with drug product and drug substance manufactured in its vertically integrated…

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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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