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NEWS

Samsung Bioepis Enters Asset Purchase Deal with Biogen for Byooviz (Biosimilar, Lucentis) and Opuviz (Biosimilar, Eylea) in the EU

Shots:Samsung Bioepis has entered an asset purchase agreement with Biogen to acquire its ophthalmology assets, Byooviz & Opuviz, biosimilar versions of Lucentis (ranibizumab) & Eylea (aflibercept), in the EUSamsung Bioepis will assume full responsibility for the commercialization of Byooviz following the transfer of rights from Biogen, effective January 2026Byooviz was approved by…
October 29, 2025

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INSIGHTS+

Key Biosimilars Events of July 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        Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the…
August 5, 2025

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NEWS

Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

Shots:Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the USByooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…
July 18, 2025

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Samsung Bioepis ans NIPRO
NEWS

Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan 

Shots:Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in JapanAs per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activitiesUstekinumab is…
June 9, 2025

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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 vialDesignation 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 continueIn 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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