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

NEWS

Samsung Bioepis Reports the Initiation of the P-I Trial Evaluation of SB27 (biosimilar, pembrolizumab) for the Treatment of Lung Cancer

Shots: The company received the MHLW’s approval to initiate a P-I clinical trial for the bioequivalence evaluation of SB27 as compared to Keytruda (pembrolizumab) The P-I clinical trial evaluates the safety, efficacy & immunogenicity of SB27 vs Keytruda in patients with Stage II-IIIA NSCLC following complete resection & adjuvant Platinum-based CT Keytruda is a PD-1-blocking…

ByDipanshu DixitFebruary 21, 2024

INSIGHTS+

Insights+ Key Biosimilars Events of September 2023

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 the month of September, Sandoz entered into a development and commercialization agreement…

BySenior EditorOctober 4, 2023

INSIGHTS+

Insights+ Key Biosimilars Events of August 2023

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 the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…

BySenior EditorSeptember 6, 2023

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

Samsung Bioepis Reports the Initiation of the P-I Trial Evaluation of SB27 (biosimilar, pembrolizumab) for the Treatment of Lung Cancer

Insights+ Key Biosimilars Events of September 2023

Insights+ Key Biosimilars Events of August 2023

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