Oncology

Biosimilar Trastuzumab Effective in Triplet Regimen for Gastric Cancer

July 10th 2020

By Skylar Jeremias

A phase 1b/2 trial evaluating a trastuzumab biosimilar as part of a first-line triplet regimen demonstrated significant tumor shrinkage in HER2-positive advanced gastric cancer.

Genentech and Amgen Cease Fire on Biosimilar Litigation

July 9th 2020

By Tony Hagen

Article

In court filings this week, Genentech and Amgen laid to rest their long-running dispute over the marketing of bevacizumab and trastuzumab biosimilars that challenged Genentech's dominance of the market for those products.

FDA Approves Adalimumab Biosimilar From Fujifilm Kyowa Kirin Biologics

July 8th 2020

By Tony Hagen

Article

The FDA has approved Fujifilm Kyowa Kirin Biologics's Hulio adalimumab biosimilar, making it the sixth adalimumab biosimilar approved in the United States. However, none will be launched before 2023 because of the strength of AbbVie's exclusivity rights for Humira, the reference product. Hulio launched in Europe in 2018.

Biocon Seeks to Take Biosimilars Unit Public by 2023

July 8th 2020

By Skylar Jeremias

Article

Biocon is planning to list its biosimilar entity, Biocon Biologics, on the capital markets in the next few years. Although this move will allow the entity to expand on current projects, it also raises questions about whether it will be successful.

Genentech Alleges Infringement by Samsung Bioepis

July 8th 2020

By Skylar Jeremias

Article

Genentech seeks to block the marketing of Samsung Bioepis’ proposed bevacizumab biosimilar, saying the company infringed multiple patents when submitting an FDA approval application.

Use of Infliximab Biosimilar in Medicare Population Is Low but Growing

July 7th 2020

By Deana Ferreri, PhD

Article

Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the part of gastroenterologists and patients, particularly when it comes to extrapolation to off-label uses, according to a new study.

Review: Nurses Can Play Key Role in Improving Biosimilar Use

July 7th 2020

By Skylar Jeremias

Article

A review laid out ways for nurses to address patients’ questions on biosimilars in order to help them take on the role of improving utilization rates in cancer treatment.

Remove the Disincentives and Biosimilars Will Flourish, Policy Expert Says

July 7th 2020

By Tony Hagen

Article

Wayne Winegarden, PhD, director of the Center for Medical Economics and Innovation, explains that misaligned incentives are preventing the United States from realizing full benefit from biosimilars.

Higher Court Sides With Amgen in Mvasi Case

July 6th 2020

By Tony Hagen

Article

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.