May 2nd 2024
Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.
As Biosimilar Competition Nears for Pegfilgrastim, a Novel Long-Acting G-CSF Agent Shows Promise
March 29th 2018Eflapegrastim is novel long-acting granulocyte-colony stimulating factor therapy. Pharmacokinetic analysis in vivo demonstrated a 2- to 3-fold increase in area under the time‐concentration curve for absolute neutrophil count versus pegfilgrastim when administered at similar doses, and the proposed drug demonstrated comparable efficacy compared with pegfilgrastim in an open-label study in patients with breast cancer who were receiving docetaxel and cyclophosphamide.
Oncologists Address the Role of Biosimilars in Cancer Care at NCCN Annual Conference
March 26th 2018During a symposium held during the 23rd annual conference of the National Comprehensive Cancer Network (NCCN), held last week in Orlando, Florida, Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center; Jeffrey Crawford, MD, of Duke University; and Lee Schwartzberg, MD, FACP, of University of Tennessee Health Science Center, presented on the use of biosimilars in oncology.
Rituximab Induction Is Cost Effective for Asymptomatic Advanced Follicular Lymphoma
March 23rd 2018Rituximab induction therapy has the highest probability of cost effectiveness in treating newly diagnosed patients with asymptomatic advanced follicular lymphoma, according to a study published in the British Journal of Haematology.
No Negative Impact on Quality of Life With Subcutaneous Trastuzumab
March 14th 2018Patients without comorbidities who received subcutaneous trastuzumab with their chemotherapy and endocrine therapy showed a significant improvement in emotional function, and reported that they were less upset by hair loss than the patients in the control group.
Low-Dose Filgrastim Provides Cost Savings and Noninferior Clinical Outcomes for Some Patients
March 6th 2018To determine whether a course of 300 ug of filgrastim, administered daily for 2 days, achieves the same clinical outcomes that have been reported with the recommended dosage, and whether such a dose could provide cost savings, investigators from Marshall University performed a retrospective chart review to identify all patients at their institution with chemotherapy-induced neutropenia who were treated with 2 consecutive doses of 300 ug of filgrastim between September 2011 and September 2016.
Cadila to Seek FDA Approval of Pegfilgrastim Biosimilar by 2019
March 2nd 2018India-based drug manufacturer Cadila Healthcare has announced that it is planning to file a Biologics License Application (BLA) for its biosimilar pegfilgrastim with the FDA by the end of 2019. To date, no developer has been successful in gaining regulatory approval in the United States or European Union for a biosimilar of the reference pegfilgrastim.
Real-World Data on Rituximab Plus CHOP in DLBCL Indicate That "Excellent Outcomes" Are Possible
March 1st 2018Treatment with rituximab plus a regimen of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) for patients with diffuse large B-cell lymphoma (DLBCL) has proven efficacy in clinical trials, few long-term data are available for the use of this combination in patients in a real-world setting.
Infliximab May Make Chemotherapy More Effective in Patients With Colon Cancer
February 27th 2018Because tumor necrosis factor-alfa (TNF) has been identified as possessing tumor-promoting properties in multiple malignant tumors, anti-TNF therapies have been proposed as a potential combination treatment that could enhance the effects of chemotherapy in patients with colon cancer.
Study Finds No Evidence of Increased Pulmonary Toxicity With Bleomycin Plus Filgrastim
February 23rd 2018In an animal model of bleomycin-induced lung toxicity, filgrastim increased alveolar neutrophil recruitment, pulmonary edema, and lung myeloperoxidase activity. That finding led to concerns about whether filgrastim could increase pulmonary toxicity when used together with adriamycin, bleomycin, vinblastine, and dacarbazine regimens.
ASCO Issues Statement on Biosimilars in Oncology
February 16th 2018This week, the American Society of Clinical Oncology (ASCO) released a new statement that seeks to offer clinicians guidance on the use of biosimilars in oncology as a wave of patent expirations is expected to bring more anti-cancer and supportive care biosimilars to the US market.
Study Supports the Effectiveness and Safety of Biosimilar Filgrastim in Patients With DLBCL
February 15th 2018A study recently published in the European Journal of Hematology reports diffuse large B-cell lymphoma (DLBCL)–specific findings from MONITOR-GCSF, a pan-European, multicenter, prospective, observational study that attempts to describe the treatment patterns and clinical outcomes of patients who received biosimilar filgrastim in the prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia.
Dr Hope Rugo: Talking With Other Prescribers About Biosimilars
February 14th 2018Hope Rugo, MD, director of the breast oncology clinical trials program at the University of California at San Francisco, disucusses the conversations she is having and expects to have with fellow prescribers about biosimilars in oncology.
Celltrion Gains the European Commission's Authorization for Biosimilar Trastuzumab, Herzuma
February 14th 2018Celltrion’s head of strategy and operations, Ho Ung Kim, told reporters this week that the intravenous Herzuma could be launched at as much as a 50% discount to a subcutaneously administered presentation of the reference Herceptin.
SB3 Shows Equivalence to Reference Trastuzumab in Phase 3 Study
January 31st 2018A study newly published in the Journal of Clinical Oncology found that SB3, a proposed trastuzumab biosimilar being developed by Samsung Bioepis, demonstrated equivalence with European-sourced reference trastuzumab (Herceptin) in terms of breast pathologic complete response (bpCR) rate. Safety and immunogenicity for the 2 drugs were also similar.
Real-World Data Support the Noninferiority of Biosimilar Filgrastim in Preventing FN
January 26th 2018Zarxio, a biosimilar filgrastim approved in the United States in 2015, was demonstrated to have no clinically meaningful differences from its reference in a randomized clinical trial setting, but data on its effectiveness in preventing febrile neutropenia (FN) a real-world setting have been limited thus far.
PK, PD Similarity Demonstrated for mAbxience's RTXM83 and MabThera
January 25th 2018A study published yesterday in Cancer Chemotherapy and Pharmacology reports that pharmacokinetic (PK) and pharmacodynamic (PD) data from a randomized, double-blind, phase 3 clinical study show similarity between mAbxience’s proposed rituximab biosimilar, RTXM83, and its reference, MabThera, using a population PK model approach.
Pfizer's PF-05280586 Shows Equivalence to Reference Rituximab in Comparative Study
January 24th 2018Pfizer announced today that PF-05280586, the company’s proposed biosimilar to reference rituximab (Rituxan, MabThera), has been shown to be equivalent to the reference in overall response rate for the first-line treatment of patients with CD20-positive, low tumor burden follicular lymphoma.