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.
Paper Raises Unanswered Questions About Subcutaneous Trastuzumab
November 4th 2018While US patients with HER2-positive cancers do not have an available subcutaneous trastuzumab option, Brazil, Canada, and the European Union have an approved product that has been shown in a phase 3 trial to be noninferior to intravenous trastuzumab.
Biosimilar Filgrastim Proves Noninferior to Reference in PBCM
October 29th 2018A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).
Positive Clinical Trial Results for 2 Proposed Pegfilgrastim Biosimilars
October 25th 2018Pegfilgrastim, a long-acting granulocyte-colony stimulating factor (G-CSF) therapy, has become a key product for the prophylaxis and treatment of febrile neutropenia, and biosimilar options have the potential to reduce the high cost of pegfilgrastim therapy. At the European Society for Medical Oncology 2018 Congress, held October 19-23, 2018, in Munich, Germany, 2 research teams presented on studies assessing proposed pegfilgrastim biosimilar products.
Biosimilar Epoetin Alfa Improves Both Hemoglobin Levels and Quality of Life
October 25th 2018Anemia is a common complication for patients who are undergoing chemotherapy, and one that has implications for patients’ quality of life, especially with respect to fatigue. During the European Society for Medical Oncology 2018 Congress, held October 19-23, 2018, in Munich, Germany, Jérôme Desrame, MD, reported on results of the CIROCO study, which assessed fatigue in patients with chemotherapy-induced anemia who were treated with biosimilar epoetin alfa.
As Reassuring Data on Anticancer Biosimilars Grow, ESMO Ups Its Biosimilar Education
October 24th 2018The European Society for Medical Oncology (ESMO) 2018 Congress, held October 19-23, 2018, in Munich, Germany, featured multiple presentations on biosimilars in oncology, all of which are contributing to the body of evidence that points to the safety and efficacy of these products. Despite such reassuring data for biosimilars, however, many stakeholders have noted that lack of provider education on biosimilars is holding back progress with uptake.
Innovent to Initiate Trial of Biosimilar Bevacizumab Plus PD-1 Inhibitor
October 24th 2018China-based drug maker Innovent Biologics has revealed that China’s National Medical Products Administration has approved its application to test a combination therapy comprising a proposed biosimilar bevacizumab product, IBI305, plus sintilimab, an anti–programmed cell death protein 1 (PD-1) monoclonal antibody.
Administering Nivestym at Home Is Effective and Well-Received by Patients
October 18th 2018A recent study provides insight into the feasibility of at-home administration of biosimilar filgrastim—Pfizer’s recently approved Nivestym—an option that has the potential to reduce patient burden associated with hospital administration.
ODAC Unanimously Recommends Celltrion's Biosimilar Rituximab for FDA Approval
October 10th 2018In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 Oncologic Drug Advisory Committee (ODAC) members voted yes, for reasons some enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”
Association of European Cancer Leagues Calls for Faster Biosimilar Uptake
October 10th 2018The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.
Ahead of ODAC Meeting, FDA Documents Say CT-P10 is Highly Similar to Rituxan
October 8th 2018The FDA's Oncologic Drugs Advisory Committee (ODAC) briefing documents state that the totality of the evidence suggests that the proposed biosimilar is highly similar to its US-licensed reference, despite minor differences in clinically inactive compounds.
Health Canada Approves Trastuzumab for Subcutaneous Administration
October 1st 2018Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).
BEVZ92 Highly Similar to Reference Bevacizumab in PK, Efficacy, Immunogenicity, and Safety
September 25th 2018Notably, the study was conducted in patients with cancer, rather than in a healthy population, to generate evidence of pharmacokinetic (PK) equivalence in a scenario that reflects how the biosimilar would be used in clinical practice.
Iranian Biosimilar Rituximab Noninferior to Its Reference in Treating CLL
September 24th 2018A recently published study between the biosimilar and the reference rituximab, MabThera, demonstrated that the biosimilar was noninferior to the reference in terms of both efficacy and safety in treating chronic lymphocytic leukemia (CLL).
Sandoz, Cinfa, Mylan All Receive CHMP Recommendations for Pegfilgrastim Biosimilars
September 21st 2018Today, Sandoz, Cinfa Biotech, and Mylan all revealed that they have received positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for proposed pegfilgrastim biosimilars referencing Neulasta.
Researchers Report Positive Early Data for Cetuximab Biosimilar
September 18th 2018Cetuximab (Erbitux), an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody used in the treatment of head and neck and colorectal cancer, so far faces no biosimilar challengers. However, Chinese researchers are reporting positive preclinical results for a proposed biosimilar, APZ001.
Patients With CLL Who Have Anaphylaxis With Obinutuzumab May Be Able to Receive Rituximab
September 16th 2018Rituximab-based immunochemotherapy can be safely applied in patients after obinutuzumab-associated anaphylaxis, but the existing risk of cross­reactivity should be considered, and careful monitoring of such patients during rituximab infusion is required.
ODAC to Discuss Celltrion's CT-P10 in October 2018
September 12th 2018Korean drug maker Celltrion says that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application (BLA) for CT-P10, a proposed biosimilar rituximab, on October 10, 2018. CT-P10 is already authorized in the European Union, where it was approved under the trade names Rituzena, Ritemvia, Truxima, and Blitzima.
Blocking PDGF Could Make Bevacizumab More Effective in Treating Glioblastoma
August 30th 2018New research suggests that inhibiting platelet-derived growth factor (PDGF), which regulates cell growth and division, could help overcome resistance to anti–vascular endothelial growth factor treatment in glioblastoma multiforme.
Lower Pain Scores With Biosimilar Pegfilgrastim After Pediatric Stem Cell Transplant
August 27th 2018There was a significant difference observed in pain scores between pediatric patients receiving pegfilgrastim versus those receiving filgrastim after allogenic hematopoietic stem cell transplantation.
Biosimilar Trastuzumab CT-P6 Launches in Japan, But Not For Breast Cancer
August 21st 2018The product did not earn approval for all indications of the reference Herceptin; it has been approved only for the treatment of HER2-positive gastric cancers, and not for the treatment of HER2-positive breast cancer.
NICE: Pertuzumab Not Cost-Effective, Even When Used With Biosimilar Trastuzumab
August 20th 2018The National Institute for Health and Care Excellence (NICE) evidence reviewers considered a biosimilar discount of 70% to 90% off the reference trastuzumab’s price at a 90% to a 100% market share, and the Cancer Drugs Fund provided the committee with confidential information on the weighted average price and market share for available biosimilar trastuzumab products.
Patient-Administered Biosimilar and Follow-On Filgrastim Pose Opportunity for Savings
August 13th 2018Studies have demonstrated that using follow-on and biosimilar granulocyte colony-stimulating factor (G-CSF) agents can produce cost savings and expand patient access to prophylaxis of febrile neutropenia. Now, a newly published budget impact analysis finds that even greater savings may be possible if patients self-administer these agents at home rather than visiting a provider to receive an injection.
Tbo-Filgrastim Gains a New Pediatric Indication and Vial Presentation
August 9th 2018Teva announced this week that the FDA has approved its tbo-filgrastim (Granix), a follow-on product referencing Neupogen, to reduce the duration of severe neutropenia in patients as young as 1 month old who have nonmyeloid malignancies and are receiving myelosuppressive chemotherapy.
Pfizer's Trastuzumab Biosimilar, Trazimera, Authorized by European Commission
July 31st 2018Pfizer announced today that the European Commission (EC) has approved its trastuzumab biosimilar, Trazimera, referencing Herceptin, for marketing. The approval makes Trazimera the fourth trastuzumab biosimilar (following Kanjinti, Ontruzant, and Herzuma) to be approved by the EC, and the first approval of an anticancer biosimilar for Pfizer.
Mylan Confirms That It Has Launched Fulphila in the United States
July 30th 2018Drug maker Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, confirmed in an email to The Center for Biosimilars® that it has launched the biosimilar in the United States marketplace. Fulphila is the fourth biosimilar—and the first pegfilgrastim biosimilar—to become available to US patients.