Oncology

Mylan and Biocon Launch Biosimilar Trastuzumab, Ogivri, in the United States

December 2nd 2019

By Kelly Davio

Mylan and Biocon have announced that their biosimilar trastuzumab, Ogivri, has become commercially available in the United States. The biosimilar, referencing Herceptin, is now available in a 420-mg multidose vial and a 150-mg single-dose vial.

Combination of Bevacizumab With Immune Checkpoint Inhibitor May Have Activity in Relapsed Ovarian Cancer

November 28th 2019

By The Center for Biosimilars Staff

Researchers have hypothesized that signaling through the vascular endothelial growth factor (VEGF) pathway could have immunomodulatory effects, and a recent study reports on a phase 2 trial that assessed a combination of the immune checkpoint inhibitor nivolumab with the anti-VEGF agent bevacizumab, which now has a commercially available biosimilar.

Sonia T. Oskouei, PharmD: Biosimilars and Innovation

November 27th 2019

Sonia T. Oskouei, PharmD, vice president of innovation and solution development at Premier Inc, discusses how biosimilars have impacted innovation in oncology.

Newly Reported Phase 3 Data Support Biosimilarity of HLX02 and Reference Trastuzumab

November 25th 2019

By Kelly Davio

During the European Society for Medical Oncology Asia Congress 2019, held last week in Singapore, a research team led by Binghe Xu, MD, PhD, department of medical oncology at the Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China, reported that the biosimilar met its primary end point of best overall response rate at week 24.

Spanish Study Finds Biosimilar Rituximab Would Need 34% Discount to Match Subcutaneous Option on Cost

November 19th 2019

By Kelly Davio

This week, a study from Spain retrospectively compared direct costs of intravenous and subcutaneous reference rituximab in the setting of lymphoma, taking into consideration drug costs, pharmacy costs, and chair time-related costs at a single center in 2017. They also conducted the same analysis using the costs of biosimilar rituximab.

The FDA Will Review Samsung Bioepis' Proposed Bevacizumab Biosimilar, SB8

November 19th 2019

By Kelly Davio

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

Novartis Confirms It Has Launched Biosimilar Pegfilgrastim, Ziextenzo, in the United States

November 15th 2019

By Kelly Davio

Novartis has confirmed in an email to The Center for Biosimilars® that it has launched Sandoz’s pegfilgrastim biosimilar, Ziextenzo, in the United States. According to Novartis, the wholesale acquisition cost (WAC) for Ziextenzo is $3925, or an approximate 37% discount off the WAC for the reference product, Amgen’s Neulasta.

Sonia T. Oskouei, PharmD: The Launch of Biosimilar Rituximab and Its Impact on Cancer Care

November 15th 2019

Sonia T. Oskouei, PharmD, vice president of innovation and solution development at Premier Inc, discusses the launch of the first rituximab biosimilar in the United States.

First Rituximab Biosimilar, Truxima, Launches in the United States

November 7th 2019

By Kelly Davio

Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.

FDA Approves Sandoz's Pegfilgrastim Biosimilar, Ziextenzo

November 5th 2019

By Kelly Davio

The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.