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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…

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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…

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Bio-Thera Collaborates with STADA for the Commercialization of BAT2506 (Biosimilar, Simponi) 

Shots: Bio-Thera and STADA have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) Under the collaboration, Bio-Thera is entitled to receive a $10M upfront and an additional $147.5M development and commercial milestones upon certain conditions fulfilment Furthermore, Bio-Thera will handle the development, manufacturing and supply activities of…

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Xbrane Biopharma and STADA Team Up with Valorum Biologics for Commercializing Xlucane (Biosimilar, Ranibizumab) Across the US 

Shots: Xbrane & STADA have signed an exclusive license agreement with Valorum Biologics to commercialize Xlucane, biosimilar of ranibizumab, across the US As per the agreement, both companies will complete the regulatory approval process; Xbrane to handle commercial manufacturing & supply. Post approval, Valorum will take care of sales, marketing & other commercial activities of…

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STADA and Alvotech’s Uzpruvo (Biosimilar, Stelara) Obtains EC’s Approval for Immune-Mediated Diseases

Shots : Followed by the CHMP’s positive opinion in Nov 2023 for Crohn’s disease, psoriasis and psoriatic arthritis, the EC has approved Uzpruvo across the EU and Iceland, Liechtenstein, and Norway The approval was based on the analytical & clinical results, data from the study (AVT04-GL-301) comparing the safety and efficacy of AVT04 vs Stelara…

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Insights+ Key Biosimilars Events of June 2023

Insights+ Key Biosimilars Events of June 2023

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars 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 the patientsDuring the month of June, Samsung Bioepis presented results of SB12…

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Insights+ Key Biosimilars Events of April 2023

Insights+ Key Biosimilars Events of April 2023

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars 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 the patientsDuring the month of April, Sandoz’s Hyrimoz (biosimilar, adalimumab) received EC’s…

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Insights+ Key Biosimilars Events of December 2022

Insights+ Key Biosimilars Events of December 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars 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 the patientsDuring the month of December, Alvotech and STADA launched Hukyndra (biosimilar, adalimumab)…

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