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Key Biosimilars Events of February 2025
INSIGHTS+

Key Biosimilars Events of February 2025

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        A major highlight was the Samsung Bioepis & Teva Partners to Commercialize…
March 4, 2025

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Teva and Alvotech
News

Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US

Shots:Alvotech and Teva have launched Selarsdi (ustekinumab-aekn) injection, a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US The FDA has provisionally determined that all Selarsdi presentations can be approved as interchangeable with Stelara after exclusivity expires on Apr…
February 24, 2025

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Teva and Alvotech
News

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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Teva & Samsung Bioepis
News

Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US

Shots:Samsung Bioepis and Teva have signed a development and commercialization license agreement for Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab), in the US Under the agreement, Samsung Bioepis will manage development, regulatory registration, manufacturing, and supply, while Teva will oversee commercialization in the US. The financial terms are confidential. This deal increases Teva's biosimilar…
February 10, 2025

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Key Biosimilars Events of January 2025
INSIGHTS+

Key Biosimilars Events of January 2025

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       A major highlight was the Samsung Bioepis & Teva Partners to Commercialize Epysqli in…
February 4, 2025

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News

Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel

Shots:Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…
January 14, 2025

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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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Insights+ Key Biosimilars Events of February 2024
INSIGHTS+

Insights+ Key Biosimilars Events of February 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 February, Sandoz received Health Canada’s approval for Jubbonti while Rani Therapeutics…
March 4, 2024

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