Oncology

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

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.