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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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Samsung Bioepis
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…
February 21, 2024

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Insights+ Key Biosimilars Events of September 2023
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…
October 4, 2023

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Insights+ Key Biosimilars Events of August 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…
September 6, 2023

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Insights+ Key Biosimilars Events of July 2023
INSIGHTS+

Insights+ Key Biosimilars Events of July 2023

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 the patients During the month of July, Samsung Bioepis reported P-III equivalence study…
August 4, 2023

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Insights+ Key Biosimilars Events of June 2023
INSIGHTS+

Insights+ Key Biosimilars Events of June 2023

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 the patients During the month of June, Samsung Bioepis presented results of SB12…
July 5, 2023

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Insights+ Key Biosimilars Events of May 2023
INSIGHTS+

Insights+ Key Biosimilars Events of May 2023

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 the patients During the month of May, Celltrion’s Yuflyma (biosimilar, adalimumab) received the…
June 7, 2023

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Insights+ Key Biosimilars Events of April 2023
INSIGHTS+

Insights+ Key Biosimilars Events of April 2023

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 the patients During the month of April, Sandoz’s Hyrimoz (biosimilar, adalimumab) received EC’s…
May 3, 2023

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