Oncology

Higher Court Sides With Amgen in Mvasi Case

July 6th 2020

By Tony Hagen

In upholding a lower court ruling, a federal circuit court has decided that Amgen gave enough notice prior to launching its bevacizumab biosimilar. The court decision has frustrated an attempt by Genentech to block sales of the product.

Study of Neupogen vs Biosimilars Draws Fire

July 6th 2020

By Tony Hagen

Article

After a study from India suggested a higher incidence of adverse reactions in patients using biosimilar filgrastims, 2 European biosimilar consultants and oncologists raised objections to the study’s methodology.

Samsung Bioepis Begins Phase 3 Trial for Aflibercept Biosimilar

June 30th 2020

By Skylar Jeremias

Article

A phase 3 clinical trial comparing the safety, efficacy, and immunogenicity of Samsung Bioepis’ aflibercept biosimilar with reference Eylea is now underway.

IQVIA Rates European Countries on Biosimilar Market Health

June 30th 2020

By Tony Hagen

Article

A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.

Samsung Bioepis' Bevacizumab Biosimilar Gets CHMP Nod

June 26th 2020

By Skylar Jeremias

Article

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis’ bevacizumab biosimilar for the treatment of multiple types of cancer.

Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says

June 25th 2020

By Deana Ferreri, PhD

Article

Investigators found that manufacturers appear to be exploiting orphan drug exclusivities to extend market dominance and keep generics and biosimilars at bay.

Bio-Thera's Avastin Biosimilar Application Accepted by NMPA

June 22nd 2020

By Skylar Jeremias

Article

China’s National Medical Products Administration (NMPA) has accepted an application for a biosimilar bevacizumab developed by Bio-Thera Solutions for treatment of certain lung and colorectal cancers.

China's NMPA Approves Innovent's Byvasda Biosimilar

June 19th 2020

By Skylar Jeremias

Article

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

Henlius Biotech's Bevacizumab Meets Primary End Point

June 19th 2020

By Tony Hagen

Article

HLX04, a bevacizumab biosimilar candidate targeted at the colorectal and non–small cell lung cancer markets, met a phase 3 study primary end point, Shanghai Henlius Biotech said.

EHA25 Virtual Roundup

June 18th 2020

By Skylar Jeremias

Video

Here is a summary of our coverage from EHA25 Virtual, the annual meeting for the European Hematology Association (EHA).