Pegstim (pegfilgrastim biosimilar) / Zydus Lifesci - LARVOL DELTA

Burkitt Leukemia - Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Ofatumumab (EPOCH - O) (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center

New P2 trial • Biosimilar • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology

Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P2; N=80; Completed; Sponsor: M.D. Anderson Cancer Center; Active, not recruiting -> Completed ; Trial primary completion date: May 2015 ->Sep 2014

Trial completion • Trial primary completion date • Biosimilar • Dyslipidemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Establishment of the first international standard for PEGylated granulocyte colony stimulating factor (PEG-G-CSF): Report of an international collaborative study. (PubMed) - "The preparation 12/188 was judged suitable to serve as the WHO IS based on in vitro biological activity data. Therefore, the preparation coded 12/188 was established by the WHO Expert Committee on Biological Standardization (ECBS) in 2013 as the WHO 1st IS for human PEGylated G-CSF with an assigned in vitro bioactivity of 10,000IU per ampoule."

Journal • Biosimilar • Colorectal Cancer • Oncology

Cadila Healthcare plans to file biosimilar Neulasta in US by 2019 end (Moneycontrol) - "Cadila Healthcare, part of Zydus Cadila group - said it is planning to file its first biosimilar Pegfilgrastim for approval in the US by end of 2019."

BLA • Biosimilar