May 15th 2024
At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
Bio-Thera's Bevacizumab Shows High Similarity to Reference Avastin in PK, Safety, Immunogenicity
April 25th 2019Bio-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.
Review Highlights Biosimilar Epoetin Alfa in Treating Anemia in Myelodysplastic Syndromes
April 23rd 2019Myelodysplastic 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 2019The 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.
Patient, Provider Views About Biosimilars for Breast Cancer in Canadian Healthcare
April 8th 2019An 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 2019Pfizer 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 2019Next 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).
Daiichi Sankyo to Accelerate BLA Submission for DS-8201
April 1st 2019Daiichi 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.
Are We Ready for Tailored Clinical Programs for Biosimilars?
March 29th 2019During 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.
Eye on Pharma: Withdrawn BLA for Novel G-CSF Expected to Compete With Pegfilgrastim
March 27th 2019Spectrum Pharmaceuticals has withdrawn its Biologics License Application (BLA) for eflapegrastim, a granulocyte colony-stimulating factor (G-CSF) therapy that the company had hoped to sell under the brand name Rolontis.
Biosimilar Filgrastim Shows How Value Can Evolve Over Time, Study Says
March 12th 2019A recent meta-analysis of reference filgrastim’s (Neupogen) role in chemotherapy since its approval in 1991 shows how the definition of value has evolved over time as biosimilars for granulocyte colony-stimulating factors (G-CSF) entered the market.
No Difference in AEs Between Sandoz's Ziextenzo and Reference Pegfilgrastim
March 12th 2019Among the data presented to regulators for the product’s approval were those arising from a phase 1 pharmacokinetic and pharmacodynamic study in healthy volunteers and those from 2 phase 3 studies in patients with breast cancer undergoing chemotherapy.
Fewer Than Half of Oncologists in ESMO Survey Report Using Biosimilars in Clinical Practice
March 11th 2019Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.
Ahead of the Arrival of US Biosimilar Trastuzumab, FDA Approves Subcutaneous Herceptin
March 5th 2019The FDA has approved a subcutaneously administered version of the brand-name trastuzumab, Herceptin. The new formulation, trastuzumab and hyaluronidase-oysk, is a combination of the anticancer agent trastuzumab and an endoglycosidase that allows for the administration of higher volumes and enhanced absorption, and it has been approved under the name Herceptin Hylecta.
China Approves Its First Biosimilar, Henlius' Rituximab
February 27th 2019Regulators in China have approved the country’s first ever biosimilar, a rituximab product referencing Rituxan. The product, HLX01, was developed by Henlius and will be primarily used in the treatment of non-Hodgkin lymphoma. Regulatory requirements that were applied in the analysis of the drug, say investigators who took part in its development, will set a precedent for analytical similarity assessments of biosimilars in China going forward.
Bevacizumab and Cost-Saving Biosimilars Could Play a Role in Treating Advanced HCC
February 22nd 2019A newly published study discussed the potential for the anti–vascular endothelial growth factor agent bevacizumab (Avastin) and its cost-saving biosimilars to be used as second-line therapy for the treatment of patients with advanced hepatocellular carcinoma (HCC) who progressed while receiving standard therapy.
On the Strength of a Discount and Biosimilar Trastuzumab Savings, NICE Recommends Pertuzumab
February 15th 2019The United Kingdom’s National Institute for Health and Care Excellence (NICE) today released a final appraisal of pertuzumab (Perjeta) together with intravenous trastuzumab and chemotherapy for the treatment of HER2-positive early breast cancer, and recommended pertuzumab for use in patients if they have lymph node–positive disease and if drug maker Roche adheres to its promised discount for the drug.
Providers Not Using Part B Drugs to Add to Profit, Research Finds
February 4th 2019The assumption that Medicare Part B payment rates lead providers to create higher drug utilization for costlier treatments in order to benefit from larger add-on payments is not correct, a recent white paper said. The paper from Xcenda, a part of AmerisourceBergen, also found similar results when looking at physician-administered drugs in the hospital outpatient setting.
Innovent Seeks Chinese Regulatory Approval for Proposed Biosimilar Bevacizumab
January 30th 2019Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration.
More Research Finds Low Awareness of Biosimilars Among Oncology Providers
January 29th 2019While a majority of survey respondents said that they were at least somewhat familiar with current developments in oncology biosimilars, analyses of open-ended definitions found that only 1 participant could fully define a biosimilar, according to researchers.
Sales of Oncology Reference Products Far Outpace R&D Costs, Study Finds
January 25th 2019Drug makers often point to substantial research and development (R&D) costs as reasons for the high prices of innovator drugs, particularly in oncology. However, some stakeholders have expressed skepticism about whether R&D costs are indeed in line with the prices that drug makers charge. In a new study published in JAMA, investigators sought to compare sales of cancer drugs with estimated R&D costs.
MAPLE Study Supports Clinical Equivalence of ABP 215 and Reference Bevacizumab
January 11th 2019This week, investigators published the results of the MAPLE study, a phase 3 trial of Amgen’s bevacizumab in comparison with the reference, Avastin, in patients with advance nonsquamous non–small cell lung cancer who were also receiving first-line chemotherapy with carboplatin and paclitaxel.
Community Oncology Alliance Forms Biosimilars Committee Aimed at Educating Providers
January 7th 2019The Community Oncology Alliance (COA) recently formed a standing Biosimilars Committee for which The Center for Biosimilars® advisory board member, Kashyap Patel, MD, a practicing medical oncologist at Carolina Blood and Cancer Care in South Carolina, was named chair alongside co-chairs immediate past president of COA, Jeff Vacirca MD, FACP, and Michael Diaz, MD, incoming COA president.