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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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Samsung Bioepis
NEWS

Samsung Bioepis Report the CHMP’s Positive Opinion of Obodence & Xbryk (Biosimilar, Prolia & Xgeva) 

Shots:  The CHMP has granted a positive opinion to Obodence (60mg pre-filled syringe) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva (denosumab), respectively  Opinion was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males (n=168), in terms of AUC from time zero to infinity &…
November 15, 2024

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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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Samsung Bioepis
NEWS

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

 Shots:    The US FDA has granted approval to the company’s BLA of Epysqli (eculizumab-aagh), a biosimilar version of Soliris (eculizumab)  Approval was supported by data from the P-I trial depicting similar PK/PD, safety, tolerability & immunogenicity profiles among healthy subjects and the P-III trial showing comparable efficacy, safety, PK & immunogenicity in PNH patients b/w Epysqli vs Soliris …
July 22, 2024

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Samsung Bioepis
NEWS

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Shots:  The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC  Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability…
June 28, 2024

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Samsung Bioepis
NEWS

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara) 

Shots:  The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC  Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability…
June 28, 2024

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Insights+ Key Biosimilars Events of April 2024
INSIGHTS+

Insights+ Key Biosimilars Events of April 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 April, Samsung Bioepis and Sandoz received the EC’s Marketing Authorization approval for Pyzchiva.…
May 2, 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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Samsung Bioepis
NEWS

Samsung Bioepis Signs a Collaboration Agreement with Samil Pharma to Co-Commercialize SB15 (biosimilar, aflibercept) for the Treatment of Ophthalmologic Conditions

Shots:   Samsung Bioepis entered into a collaborative agreement with Samil Pharmaceuticals to co-commercialize SB15, a biosimilar version for Eylea (aflibercept) for the treatment of wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) across Korea   Earlier in Jun 2022, both companies had collaborated to jointly commercialize Amelivu, a biosimilar version of Lucentis for the…
March 1, 2024

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Samsung Bioepis
NEWS

Samsung Bioepis Highlights 2 Abstracts for SB17 (biosimilar, ustekinumab) for the Treatment of Moderate-to-Severe Psoriasis at ECCO 2024  

Shots:    The first study highlights the results from the analytical assessment of the safety & efficacy of SB17 vs Stelara (ustekinumab) which demonstrated SB17 to be biologically similar to Stelara in terms of its physicochemical, structural & biological attributes   Additionally, the data supports the similarity of SB17 with reference Stelara in terms of the biosimilarity, PK,…
February 22, 2024

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