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.
Mylan to Launch Fulphila at 33% Discount to Neulasta
July 17th 2018In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.
Consequences of Switching to Anticancer Biosimilars Are "Unknown," Concludes Appraisal
July 16th 2018Biosimilars of anticancer monoclonal antibodies are emerging in the therapeutic landscape, and while the body of evidence concerning switching to supportive care biosimilars—epoetin and filgrastim biosimilars—is robust, there are fewer data available concerning a switch to biosimilars of products such as rituximab, trastuzumab, and bevacizumab.
Intratumoral Injections of Bevacizumab Could Help Prevent AEs Associated With Systemic Therapy
July 3rd 2018Intravenous administration of the anti–vascular endothelial growth factor treatment bevacizumab at high doses can result in serious, systemic adverse events (AEs). Additionally, tumors can become resistant to therapy and adopt a more invasive growth pattern. Thus, delivering bevacizumab for the treatment of cancer at a lower dose in a manner that avoids systemic AEs is necessary.
Report Details Novel Methods to Improve Clinical Use of CAR T-Cell Immunotherapies
June 25th 2018Researchers have reported the development of CubiCAR architecture, which has the potential to improve the safety of chimeric antigen receptor (CAR) T-cell immunotherapies for a broad range of patients with cancer.
New Directions in Oncology Biosimilars
June 8th 2018During a session at the 2018 American Society of Clinical Oncology Annual Meeting, held June 1-5 in Chicago, Illinois, researchers gave a glimpse into new directions in oncology biosimilars through providing results on several studies testing the safety, efficacy, and usage of different biosimilars.
Research Reports on Rituximab in Treating MCL and DLBCL
June 7th 2018During the 2018 American Society of Clinical Oncology Annual Meeting, researchers published new findings on the use of rituximab in mantle cell lymphoma (MCL) as well as the outcomes of patients who relapse early after treatment with rituximab for diffuse large B-cell lymphoma (DLBCL).
Real-World Evidence Shows Benefits of On-Body Pegfilgrastim, But Low Use of G-CSF Agents
June 6th 2018Clinical practice guidelines recommend the use of granulocyte-colony stimulating factor (G-CSF) therapies, including the long-acting pegfilgrastim (Neulasta), for the prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy. Real-world data, published in an abstract concurrent with the 2018 American Society of Clinical Oncology Annual Meeting, demonstrate the feasibility of administering pegfilgrastim via an on-body device.
Biosimilar, Follow-On Filgrastim Feature in New Research on FN and Peripheral Stem Cell Mobilization
June 5th 2018Research published in conjunction with the 2018 American Society of Clinical Oncology Annual Meeting presented new findings on the use granulocyte-colony stimulating factor agents in treating febrile neutropenia (FN) and in peripheral stem cell mobilization.
Apobiologix's Biosimilar Pegfilgrastim Approved in Canada
June 4th 2018On June 1, drug maker Apotex announced that its Apobiologix division has received approval from Health Canada for its pegfilgrastim biosimilar, Lapelga. Lapelga is the first pegfilgrastim biosimilar to be approved in a highly regulated territory.
Panel Grapples With the Role of Biosimilars in Oncology
June 1st 2018On Friday morning in Chicago, Illinois, The Atlantic hosted a series of panels, moderated by Steve Clemons, on the role biosimilars in cancer care. Opening the morning’s proceedings were Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and Chadi Nabhan, MD, MBA, FACP, CMO of Cardinal Health Specialty Solutions.
COA Sues HHS, OMB Over Medicare Sequester Cuts
June 1st 2018This week, the Community Oncology Alliance (COA), which represents approximately 5000 community oncologists, announced that it has filed a lawsuit against HHS, HHS Secretary Alex Azar, the Office of Management and Budget (OMB), and the director of the OMB, Mick Mulvaney, in the District of Columbia to stop the departments from applying the Medicare sequester cut to reimbursement for Part B drugs.
Cyclophosphamide-Bevacizumab as Second-Line Chemo in Advanced Recurrent Cervical Cancer
May 7th 2018Some cervical cancer patients with advanced or recurrent disease suffer from anaphylaxis after taxane- or platinum-based therapy, and there is no standard treatment for progressive disease that develops during or shortly after platinum-based chemotherapy. Doctors and patients have therefore sought the development of a non-taxane, non-platinum regimen for recurrent cervical cancer.
Long-Term Trastuzumab Poses No Additional Cardiac Risk, Study Suggests
May 4th 2018While treatment with trastuzumab is the standard of care for HER2-positive locally advanced or metastatic breast cancer and gastric cancer, data on long-term use of the biologic are lacking, and cardiac risk related to trastuzumab has posed concerns.
"Not So Different" Episode 7: Oncology Biosimilars
April 22nd 2018Last time on the podcast, we spoke with a practicing rheumatologist about his experience with biosimilars so far, but one of the most exciting prospects on the biosimilars horizon is the market entry of 2 approved anticancer biosimilars: trastuzumab and bevacizumab. This week, we’re delving into the world of supportive care and anticancer biosimilars with an oncology expert, Robert M. Rifkin, MD, FACP.
Session Highlights Barriers to Biosimilar Adoption and Lack of Provider, Payer Education
April 17th 2018During a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance April 12-13 in National Harbor, Maryland, Robert M. Rifkin, MD, FACP, medical director of biosimilars at McKesson Specialty Health, The US Oncology Network, highlighted the opportunities biosimilars provide to increase access to drugs while decreasing costs, but also the remaining barriers to adoption.
Oncologist Sees Biosimilars Playing a Role in the Oncology Care Model
April 12th 2018Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, told The Center for Biosimilars® in an interview that, as his practice has begun to implement the Oncology Care Model, it has moved 100% of its patients to biosimilar filgrastim, Zarxio, from the reference filgrastim, Neupogen.
Study Suggests That Two AEs May Predict Improved Outcomes With Bevacizumab
April 9th 2018A recent study concludes that both hypertension and proteinuria, which are considered to be interrelated with the pharmacological action of bevacizumab, have the potential to indicate greater likelihood of therapeutic efficacy.
FDA Rejects Celltrion's Rituximab and Trastuzumab Biosimilars
April 5th 2018Today, Celltrion announced that the FDA has issued Complete Response Letters (CRLs) for 2 of its products, CT-P10, a proposed rituximab biosimilar referencing Rituxan, and CT-P6, a proposed trastuzumab biosimilar referencing Herceptin.