Skip to content Skip to footer
Subscribe Now
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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

Load more