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Samsung Bioepis
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
Coherus BioSciences Launches an On Body Injector for the Administration of Udenyca (biosimiolar, pegfilgrastim) to Treat Non-Myeloid Malignancies
Shots:   The US FDA approved Udenyca Onbody earlier in Dec 2023, as an OBI device to administer Udenyca, a biosimilar of pegfilgrastim. The company has launched Udenyca in the US market for the treatment of patients with non-myeloid malignancies    Udencya is a leukocyte growth factor indicated to be administered the day after CT to lower the rate…
February 21, 2024
Samsung Bioepis
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
Celltrion
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
Pfizer New
Pfizer’s Velsipity (etrasimod) Receives the European Commission’s Approval for the Treatment of Severely Active Ulcerative Colitis 
Shots:   The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma   Patients in the trial have previously received 1-3 prior lines of therapy,…
February 19, 2024
Mabwell Highlights Results from the P-III Study of MW032 (biosimilar, denosumab) for Solid Tumors in JAMA Oncology 
Shots:  The results from the P-III trial comparing MW032’s (SC, Q4W, until wk. 49) safety, efficacy & PK vs reference drug (denosumab) to treat patients (n=708), randomized 1:1, with solid tumors having bone metastasis are published in JAMA Oncology  The 1EP includes percentage change in natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr) from baseline to…
February 19, 2024
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