Celltrion’s CT-P39 (biosimilar, omalizumab) Receives the CHMP’s Recommendation for Marketing Authorization to Treat Multiple Indications

Shots: EMA received CHMP’s recommendation to grant marketing authorization for full-label application of Celltrion’s CT-P39, developed as a biosimilar to Xolair (omalizumab). The company expects to receive EC’s approval by early May 2024 Xolair is a monoclonal antibody approved for the treatment of various indications incl. Allergic Asthma, Nasal Polyps, and Chronic Hives. Recently, Xolair…

ByDipanshu DixitMay 23, 2024

NEWS

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Shots: Celltrion has reported BLA submission for CT-P39, biosimilar version of Xolair (omalizumab), to the US FDA for all indications as of the reference product incl. asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) & CSU The submission was supported by the data, showing comparable efficacy & safety, from P-III study…

ByDipanshu DixitMarch 10, 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

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…

ByDipanshu DixitFebruary 24, 2024

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,…

ByDipanshu DixitFebruary 21, 2024

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…

ByDipanshu DixitJanuary 28, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in October 2023

Shots: The US FDA approved 5 NDAs & 9 BLAs in October 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023 In October 2023, the major highlights drugs were Velsipity (Etrasimod) approved for Ulcerative Colitis, and Bimzelx (bimekizumab) for the Treatment of Adults…

BySenior EditorNovember 15, 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…

BySenior EditorAugust 4, 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…

BySenior EditorJuly 5, 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…

BySenior EditorJune 7, 2023

Celltrion’s CT-P39 (biosimilar, omalizumab) Receives the CHMP’s Recommendation for Marketing Authorization to Treat Multiple Indications

Celltrion Submits BLA to the US FDA for CT-P39 (Biosimilar, Xolair)

Insights+ Key Biosimilars Events of February 2024

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

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

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

Insights+: The US FDA New Drug Approvals in October 2023

Insights+ Key Biosimilars Events of July 2023

Insights+ Key Biosimilars Events of June 2023

Insights+ Key Biosimilars Events of May 2023

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