Tocilizumab

Celltrion's biosimilar for Roche's Actemra (tocilizumab), Avtozma, approved by Korea's Ministry of Food and Drug Safety for RA, sJIA, and pJIA. Also received positive opinion from EMA's CHMP and completed FDA application, making Celltrion the first to secure biosimilar approval for Actemra in Korea.

Celltrion Inc. is closer to commercializing four biosimilars in Europe after EMA's CHMP recommended approval. The biosimilars, targeting inflammatory autoimmune diseases, bone cancer, and eye diseases, aim to expand Celltrion's portfolio to 11 products by 2025 and 22 by 2030. The global market for these biosimilars is estimated at 135 trillion won.

Celltrion received CHMP recommendations for European market authorization for four biosimilars: Avtozma (Actemra biosimilar), Eydenzelt (Eylea biosimilar), and two Prolia-Xgeva biosimilars, Stoboclo and Osenvelt. These approvals strengthen Celltrion's global market position, targeting 11 biosimilar products by 2025.

Celltrion received CHMP approval recommendations for 4 biosimilars: Aptozma (Actemra), EYDENZELT (EYLEA), STOBOCLO (PROLIA-XGEVA), and OSENVELT. These expand from autoimmune and cancer treatments to bone and eye diseases, targeting a global market of approximately KRW 24 trillion. Celltrion aims to complete 11 product portfolios by 2025, with a potential global market of about 135 trillion won.

Real-world data on CD19-directed CAR T-cell therapy lisocabtagene maraleucel (liso-cel) in relapsed/refractory large B-cell lymphoma (LBCL) show similar safety and efficacy to pivotal trials. Median progression-free survival (PFS) and overall survival (OS) were not reached (NR) at 6.4 months follow-up. Objective response rate (ORR) was 84%, with a complete response (CR) rate of 70%. Liso-cel demonstrated deep responses in a broad patient cohort, supporting its use as a second-line treatment regardless of age.

Real-world data on liso-cel (Breyanzi) in relapsed/refractory large B-cell lymphoma (LBCL) showed safety and efficacy comparable to pivotal trials, with median progression-free survival (PFS) and overall survival (OS) not reached (NR) at 6.4 months follow-up. Objective response rate (ORR) was 84% with a complete response (CR) rate of 70%, and median duration of response (DOR) was NR. These results support liso-cel as a second-line standard-of-care treatment for LBCL.

Liso-cel therapy in relapsed/refractory large B-cell lymphoma showed consistent PFS and OS with prior trials, with median PFS and OS not reached at 6.4 months follow-up. ORR was 84% with a CR rate of 70%, and median DOR was NR. Safety profile consistent with previous reports, with most patients experiencing low-grade CRS and ICANS.

At the 66th ASH Annual Meeting, Jason Wang, MD, discussed a significant decrease in CRS and ICANS severity with axi-cel therapy in R/R LBCL patients, attributed to bridging therapy and preemptive steroid use. This trend improves patient outcomes and reduces healthcare costs, though long-term QOL and OS data are still limited.

New denosumab biosimilar HLX14 nears FDA approval, supported by comparative studies. CT-P47 tocilizumab biosimilar shows similar safety and efficacy to reference in RA treatment. CT-P41 denosumab biosimilar demonstrates equivalent efficacy and safety in osteoporosis patients, with no impact of anti-drug antibody status on outcomes.

The FDA's November 2024 approval of obecabtagene autoleucel (obe-cel) for relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) adds to existing CAR T-cell therapies, offering a potentially safer profile. Experts discuss the differences in costimulatory domains and persistence of CAR T-cells, highlighting obe-cel's faster off-rate and reduced toxicity. Long-term survival data from ZUMA-3 and FELIX studies show promising outcomes, with obe-cel demonstrating high CR/CRi rates and manageable safety profiles. Challenges in access, AE management, and supportive care are also addressed, emphasizing the need for specialized centers and close monitoring.