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Samsung Bioepis and Organon
NEWS

Samsung Bioepis and Organon’s Hadlima (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots: FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vial Designation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO…
May 28, 2025

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Sandoz
NEWS

Sandoz Launches Pyzchiva Autoinjector (Biosimilar, Stelara) in the EU for Chronic Inflammatory Diseases

Shots: Sandoz has launched Pyzchiva autoinjectors, a biosimilar version of Stelara (ustekinumab) in EU to treat pts (≥6yrs.; ≥60kg) with plaque PsO, PsA, Crohn’s disease & pediatric plaque PsO; commercially available in Spain, with further expansion to continue In Sep 2023, Sandoz & Samsung Bioepis entered into a development & commercialization agreement, granting Sandoz rights to…
May 23, 2025

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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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Samsung Bioepis
NEWS

Samsung Bioepis Reports the US FDA’s approval of Ospomyv & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: The EC has approved SB16: Ospomyv (denosumab-dssb; 60mg pre-filled syringe) & Xbryk (denosumab-dssb; 120mg vial), a biosimilar version of Prolia & Xgeva for osteoporosis & prevention of skeletal related events, respectively Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males, in terms of AUC from…
February 16, 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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Insights+ Key Biosimilars Events of July 2024
INSIGHTS+

Insights+ Key Biosimilars Events of July 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      The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…
August 1, 2024

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