Oncology

Innovent and Eli Lilly's Rituximab Biosimilar Meets Primary End Points in PK and Phase 3 Studies

May 9th 2019

By The Center for Biosimilars Staff

China-based biosimilar developer Innovent and Eli Lilly and Company announced this week that 2 studies of IBI301, a proposed rituximab biosimilar being jointly developed by the 2 drug makers, met their primary end points.

Roche Gets a Boost from New Kadcyla Indication as US Biosimilars of Herceptin Near

May 7th 2019

By Kelly Davio

Yesterday, the FDA approved Roche’s ado-trastuzumab emtansine (Kadcyla) for the adjuvant treatment of HER2-positive early breast cancer in patients who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based therapy. The new indication could help to stave off some of the impact of biosimilar trastuzumab, which is expected to launch this year.

Canadian Organizations Collaborate on Oncology Biosimilars Initiative

May 6th 2019

By Allison Inserro

With additional biosimilars expected to reach the market later this year and beyond, Canada has made another move to foster biosimilar adoption with 2 recent developments.

Sandoz and EirGenix to Partner on Biosimilar Trastuzumab, EG12014

April 30th 2019

By Kelly Davio

Sandoz has announced that it has entered into a partnership with Taiwan-based biotechnology manufacturing and development company EirGenix, Inc, for a proposed trastuzumab biosimilar referencing Herceptin.

Lee Schwartzberg, MD, FACP: Challenges With Incorporating Biosimilars in the Clinic

April 29th 2019

Lee Schwartzberg, MD, FACP, medical director and senior partner at The West Clinic, explains what he sees as the main challenges with incorporating biosimilars in the cancer clinic.

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

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

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

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

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.