Oncology

CHMP Issues Positive Recommendation for Juta Pharma's Pegfilgrastim Biosimilar

April 29th 2019

By The Center for Biosimilars Staff

Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.

Bio-Thera's Bevacizumab Shows High Similarity to Reference Avastin in PK, Safety, Immunogenicity

April 25th 2019

By The Center for Biosimilars Staff

Article

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, has reported the results of a clinical study of its proposed bevacizumab biosimilar, BAT1706, referencing Avastin.

Biosimilar Filgrastim Similar to Reference Product When Used in NSCLC

April 24th 2019

By Allison Inserro

Article

New data from a subset analysis of MONITOR‐GCSF, a multicenter study from Europe, show that biosimilar filgrastim has similar effectiveness and safety to reference filgrastim (Neupogen).

Review Highlights Biosimilar Epoetin Alfa in Treating Anemia in Myelodysplastic Syndromes

April 23rd 2019

By The Center for Biosimilars Staff

Article

Myelodysplastic syndromes, which are a diverse group of neoplasms that arise from hematopoietic stem cells, are characterized by ineffective hematopoiesis, leading to cytopenias such as anemia and neutropenia.

Updated ASCO and ASH Guidelines on Managing Anemia Support Safety, Efficacy of Biosimilar ESAs

April 16th 2019

By The Center for Biosimilars Staff

Article

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) first published their guidelines on erythropoiesis-stimulating agents (ESAs) in cancer care in 2002, with updates in 2007 and 2010, and the new update is the first to address biosimilar epoetin alfa.

Diverging from US, Canada Approves Biosimilar Rituximab in Both Oncology and Rheumatology Indications

April 15th 2019

By Kelly Davio

Article

Last week, Health Canada approved Celltrion and Teva’s biosimilar rituximab, Truxima, for the treatment of adults with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Patient, Provider Views About Biosimilars for Breast Cancer in Canadian Healthcare

April 8th 2019

By Allison Inserro

Article

An advocacy group for patients with breast cancer in Canada recently published a series of recommendations after convening roundtable discussions with both patients and providers about their knowledge of biosimilars.

Eye on Pharma: Pfizer Launches Trazimera in Spain

April 8th 2019

By The Center for Biosimilars Staff

Article

Pfizer has launched its biosimilar trastuzumab, Trazimera, in Spain. The biosimilar became available to Spanish patients with early and locally advanced or metastatic HER2-positive breast cancer and HER2-positive metastatic gastric cancer on April 1, 2019.

Researchers Provide Updates on Benefits of Bevacizumab in NSCLC

April 4th 2019

By The Center for Biosimilars Staff

Article

Next week, researchers from around the globe will gather in Geneva, Switzerland, for the 2019 European Lung Cancer Congress. During the meeting, multiple research teams will discuss new findings from research into the use of bevacizumab—which now has approved biosimilars that promise cost savings and expanded patient access—in nonsquamous non–small-cell lung cancer (NSCLC).

Sandoz Resubmits BLA for Pegfilgrastim Biosimilar

April 3rd 2019

By Kelly Davio

Article

Sandoz announced today that it has resubmitted to the FDA its Biologics License Application (BLA) for its proposed biosimilar pegfilgrastim.