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…

ByDipanshu DixitFebruary 4, 2025

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 &…

ByDipanshu DixitNovember 15, 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…

ByDipanshu DixitAugust 1, 2024

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 …

ByDipanshu DixitJuly 22, 2024

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…

ByDipanshu DixitJune 28, 2024

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…

ByDipanshu DixitJune 28, 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.…

ByDipanshu DixitMay 2, 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…

BySenior EditorMarch 4, 2024

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…

ByDipanshu DixitMarch 1, 2024

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,…

ByDipanshu DixitFebruary 22, 2024

Key Biosimilars Events of January 2025

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

Insights+ Key Biosimilars Events of July 2024

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

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

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

Insights+ Key Biosimilars Events of April 2024

Insights+ Key Biosimilars Events of February 2024

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

Contact US

OUR INFORMATION

FOLLOW US