Meir Rinde, MS

Health Canada approved biosimilars Brenzys and Erelzi in August 2016 and April 2017, respectively. The study tracked effects of the first phase of the British Columbia Ministry of Health’s Biosimilar Initiative, which required patients to switch to biosimilars starting in May 2019.

Many governments have aligned their guidelines with those published by the World Health Organization (WHO) and the European Medicines Agency (EMA).

Two biosimilars, Pfizer’s Zirabev and Amgen’s Mvasi, have been approved for indications including unresectable, locally advanced NSCLC and recurrent or metastatic nonsquamous NSCLC. BI 695502 is no longer under development by Boehringer Ingelheim.

In a recent paper, Sarfaraz K. Niazi, PhD summarizes some of his central ideas on the relevance of FDA biosimilar testing standards.

The arrival of biosimilars for filgrastim and pegfiltrastim coincided with higher use of granulocyte colony-stimulating factor (G-CSF) for prophylaxis against febrile neutropenia, but many high-risk patients still do not receive the treatment.

Researchers report findings that suggest a different reimbursement system for Medicare Part B biologics could lead to significantly more robust savings.

European Medicines Agency (EMA) officials said their pilot was based on wrong assumptions about the biosimilar development process.

The conservative think tank Pacific Research Institute (PRI) calculated potential biosimilar savings across multiple market share scenarios.