Oncology

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.

During the 2019 American Society of Clinical Oncology Annual Meeting, researchers said that, for payers with large populations, the discounted biosimilar pegfilgrastim can produce substantial cost savings that can be applied to offer increased access to supportive care.

Between patients treated with the biosimilar and those treated with the reference product who were not exposed to lots of Herceptin with lower antibody-dependent cell-mediated cytotoxicity, no difference was observed in event-free survival (EFS) or overall survival (OS).

“Our results suggest that in patients with a contraindication to immunotherapy, such as connective tissue, rheumatologic, or interstitial lung disease, bevacizumab may be a reasonable alternative, instead of pembrolizumab, to add to carboplatin-pemetrexed,” said lead author, Stephen J. Bagley, MD, MSCE, assistant professor of hematology-oncology at Abramson Cancer Center, in a statement.

During this week’s meeting of the International Society for Pharmacoeconomic and Outcomes Research, held from May 18 to 22 in New Orleans, Louisiana, researchers presented findings on both the patient attitudes toward granulocyte colony-stimulating factor (G-CSF) therapies and their effectiveness in the prophylaxis of febrile neutropenia.

Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, discusses how biosimilars could impact the cost of care.

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.

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.

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

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 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.

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).

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.

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.

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.

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.

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.

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

Daiichi Sankyo has announced that it is accelerating its Biologics License Application (BLA) for DS-8201, [fam-] trastuzumab deruxtecan for the treatment of patients who previously received ado-trastuzumab emtansine (Kadcyla), to the first half of 2019.

Pfizer’s biosimilar filgrastim, Nivestym, was approved by the FDA in July 2018 and launched in the United States in October 2018. Among the data on which the approval was based were 3 comparative clinical assessments of the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of the biosimilar versus the US-licensed reference filgrastim (Neupogen) in both male and female healthy volunteers. Results from these studies were reported in full last week.

During the second day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of experts discussed the current state of the regulatory landscape and considerations for tailoring clinical programs in the years ahead.