Clinical

A recent study found that rituximab maintenance therapy provides no additional benefit for patients with diffuse large B‐cell lymphoma (DLBCL) who are in complete remission after receiving rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy.
 
This week, researchers reported updated results from a post hoc subgroup analysis from the adjuvant period of treatment in the biosimilar’s phase 3 trial; these results, say the authors, demonstrate that the biosimilar, used in the adjuvant setting, has comparable efficacy and safety to the reference at 1 year.
Samsung Bioepis has begun recruiting patients with paroxysmal nocturnal hemoglobinuria (PNH) in India for a phase 3 clinical study of its proposed eculizumab biosimilar, SB12, referencing Soliris.
LG Chem’s biosimilar etanercept, LBEC0101, referencing Enbrel, recently gained approval in Japan and the Republic of Korea. Among the data that led to its authorization were those deriving from a phase 3 study that demonstrated the biosimilar had equivalent efficacy and a comparable safety profile to the reference product. Recently, researchers reported on a single-arm, open-label extension study in patients with rheumatoid arthritis (RA) who completed the 52-week phase 3 study.
This week, a pair of papers detailing the clinical program for the biosimilar appeared in Pharmacology Research and Perspectives.
This month, researchers published data from a phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA) after previous phase 3 data were reported for a study in patients with severe plaque psoriasis.
Samsung Bioepis’ etanercept biosimilar, SB4, has been available in multiple markets since it was authorized by the European Commission in 2016, and this week, a new systematic review reported on real-world evidence on the use of the biosimilar in treating inflammatory diseases.
Data continue to accrue on the use of biosimilar infliximab, CT-P13 (Inflectra, Remsima), in a variety of disease states, and a recent study among patients with ankylosing spondylitis (AS) who were treated with the biosimilar demonstrated infrequent discontinuation of therapy.
 
Celltrion announced that it has begun recruiting patients with inflammatory bowel disease in Ohio for a phase 3 clinical trial of its subcutaneous formulation of biosimilar infliximab, CT-P13 (Inflectra, Remsima). The study is intended to support an application for the formulation to the FDA.
Novartis, developer of the brand-name Lucentis, announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted the drug a positive opinion for the treatment of retinopathy of prematurity in infants.

Click here to view Biosimilars CME Activities

Click here to view Biosimilars PTCE Activities


Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747
Copyright © 2006-2019 Intellisphere, LLC. All Rights Reserved.