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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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Celltrion
NEWS

Celltrion Reports the MAA Submission to the MFDS Korea for CT-P47 (biosimilar, tocilizumab) to Treat Various Indications  

Shots:   The submission was based on the results from the P-III clinical trials evaluating the equivalence & similarity of CT-P47 vs Actemra (tocilizumab) in patients (n=471) with rheumatoid arthritis (RA)   Moreover, based on these results the company also expects to accelerate its marketing authorization application across Canada & other countries. The company expects to receive…
February 24, 2024

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Celltrion
NEWS

Celltrion Presents the Long-Term Data for CT-P13 (biosimilar, infliximab) to Treat Inflammatory Bowel Disease (IBD) at ECCO 2024 

Shots:  The company presented 2yrs. results from the P-III (LIBERTY-CD) & (LIBERTY-UC) trial evaluating the superiority in safety & efficacy of CT-P13 (SC) vs Remicade in patients (n=180 & 237) with moderately to severely active CD & UC   In the trials, 85.6% & 87% of patients completed the extension phase with clinical remission, clinical response,…
February 21, 2024

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Celltrion
NEWS

Celltrion Reports BLA Submission for CT-P47 (Biosimilar, Actemra) to the US FDA for Treating Rheumatoid Arthritis

Shots : Celltrion has submitted BLA to the US FDA seeking approval for CT-P47 in both IV and SC route of administrations based on the P-III study    The P-III study assesses the safety, efficacy, PK, and immunogenicity of CT-P47 vs Actemra for treating moderate to severe active rheumatoid arthritis with inadequate response to methotrexate…
January 28, 2024

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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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Insights+ Key Biosimilars Events of March 2023
INSIGHTS+

Insights+ Key Biosimilars Events of March 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 March, Biogen launched Byooviz (biosimilar, ranibizumab) for…
April 5, 2023

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