Oncology

Researchers Report Positive Early Data for Cetuximab Biosimilar

September 18th 2018

By The Center for Biosimilars Staff

Cetuximab (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 2018

By Jackie Syrop

Article

Rituximab-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 2018

By The Center for Biosimilars Staff

Article

Korean 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 2018

By The Center for Biosimilars Staff

Article

New 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 2018

By Kelly Davio

Article

There 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 2018

By Samantha DiGrande

Article

The 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 2018

By The Center for Biosimilars Staff

Article

The 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 2018

By Kelly Davio

Article

Studies 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 2018

By The Center for Biosimilars Staff

Article

Teva 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 2018

By Kelly Davio

Article

Pfizer 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.