Kelly Davio

July 26, 2019

Fourteen parties have submitted comments on the guidance; in addition to other concerns with the document, including calls for clarification on the use of non-US comparator products and the potential for the waiver of bridging studies in the biosimilar development process, some drug makers called on the FDA to clarify issues associated with lot-to-lot variation and quality attributes.

July 25, 2019

Among the data that supported the biosimilar’s approval was a phase 3 study in patients with advanced nonsquamous non–small cell lung cancer. This week, researchers published detailed findings from that study.

July 24, 2019

Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.

July 24, 2019

The Senate Finance Committee has released its long-awaited chairman’s mark of the Prescription Drug Pricing Reduction Act of 2019. The bill, aimed at lowering the cost of drugs for American patients, contains a number of provisions that impact biosimilars.

July 23, 2019

The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

July 23, 2019

"We argue that the default should be that biosimilars are interchangeable, unless there is compelling evidence otherwise," write Hans C. Ebers, PhD, of Biogen, and Hubb Schellekens, MD, PhD, of Utrecht University.

July 22, 2019

Sandoz announced today that it has enrolled its first patient in a combined phase 1 and phase 3 study of its proposed denosumab biosimilar versus EU-authorized Prolia.

July 19, 2019

When the Senate Committee on Health, Education, Labor, and Pensions released bipartisan legislation aimed at lowering the cost of healthcare in the United States in May, biosimilar stakeholders had some cause for optimism. However, one provision of the bill that has garnered significantly less attention from the broader healthcare community has raised concerns among many biologics stakeholders.

July 19, 2019

The first anticancer biosimilars have arrived on the US market. Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.

July 18, 2019

Patients with inflammatory diseases in the United States continue to wait for the availability of a biosimilar etanercept, despite the 2016 approval of Erelzi and the 2019 approval of Eticovo. However, in the European context, biosimilar etanercept is already available, and recently presented data demonstrate that, in some countries, use of the biosimilar is high and making an impact on healthcare costs.