Oncology

EMA to Review Henlius' Trastuzumab Biosimilar, HLX02

June 24th 2019

By The Center for Biosimilars Staff

China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.

Interim Results From REFLECT Show No New Safety Concerns for Biosimilar Rituximab, Rixathon

June 20th 2019

By Kelly Davio

Article

During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers presented their interim safety results from the REFLECT study, a prospective, noninterventional, observational, multicenter, open-label study of the biosimilar rituximab Rixathon as a curative therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated CD20-positive diffuse large B-cell lymphoma.

Real-World Data Reaffirm Biosimilar Filgrastim's Safety and Efficacy

June 19th 2019

By Kelly Davio

Article

During the 24th European Hematology Association (EHA) Congress, researchers from the European branch of the Severe Chronic Neutropenia International Registry reported on experience with reference granulocyte colony-stimulating factor products and a biosimilar.

Four Studies Report Real-World Data on Biosimilar Rituximab, Truxima

June 18th 2019

By Kelly Davio

Article

The FDA recently approved biosimilar rituximab CT-P10, or Truxima. While the drug is not yet available in the United States, data are accruing for its use in Europe. During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, 4 groups of researchers reported on real-world data that support the use of the biosimilar in cancer care.

FDA Approves Amgen's Trastuzumab Biosimilar, Kanjinti

June 13th 2019

By The Center for Biosimilars Staff

Article

Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

Amgen's Trastuzumab Biosimilar, Kanjinti, Clinically Similar to Herceptin in Cardiac Safety

June 6th 2019

By Kelly Davio

Article

During this week’s 2019 American Society of Clinical Oncology Annual Meeting, researchers reported on the cardiac safety of Amgen’s biosimilar trastuzumab, ABP 980 (approved in the European Union under the name Kanjinti), versus the reference trastuzumab, Herceptin.

Developers Provide Updates on 3 Biosimilar Pegfilgrastim Programs

June 5th 2019

By The Center for Biosimilars Staff

Article

Multiple biosimilars of pegfilgrastim are available in both the United States and Europe, and the field of competitors to Amgen’s brand-name Neulasta continues to expand. During the 2019 American Society of Clinical Oncology Annual Meeting, 3 research teams shared their findings on biosimilar pegfilgrastim development programs from sponsors Sandoz, Fresenius Kabi, and Gema Biotech.

Real-World Data Underscore the Safety and Highlight the Acceptance of Biosimilar Rituximab

June 4th 2019

By Kelly Davio

Article

While no biosimilar rituximab products have yet become available in the United States, biosimilar rituximab products are available in the European Union, and data on their use, published concurrently with the 2019 American Society of Clinical Oncology Annual Meeting, highlight not only their safety but also their growing acceptance among prescribers in Europe.

PBM Launches Oncology Biosimilar Medical Pharmacy Initiative

June 4th 2019

By The Center for Biosimilars Staff

Article

Ahead of the anticipated 2019 marketing of FDA-approved anticancer biosimilars in the United States, pharmacy benefit manager (PBM) Magellan Rx Management today announced the launch of an oncology biosimilar program.

Phase 3 and Postmarketing Data Support the Efficacy and Safety of Biosimilar Trastuzumab, Ogivri

June 4th 2019

By Kelly Davio

Article

During this week’s 2019 American Society of Clinical Oncology Annual Meeting, researchers presented the final overall survival results from the phase 3 HERITAGE study of biosimilar trastuzumab, Ogivri. In addition, another research group shared its findings on postmarketing surveillance of Ogivri in Brazil.