Skylar Jeremias

November 08, 2023

Samsung Bioepis releases data for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.

November 07, 2023

A Chinese randomized study in healthy participants found comparable pharmacokinetic, pharmacodynamic, and safety profiles between LY01011, a denosumab biosimilar, and its originator (Xgeva).

November 05, 2023

On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.

November 03, 2023

Here are the top 5 biosimilar articles for the week of October 30, 2023.

November 02, 2023

An international survey found that providers agree that use of biosimilars in inflammatory bowel disease (IBD) is safe and effective in both patients who are treatment-naïve and those who are already being treated with a reference agent.

November 01, 2023

The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). The biosimilar was also approved with an interchangeability designation.

November 01, 2023

Between 3 regulatory approvals, 2 complete response letters, and new data and industry insights, October brought a number of business updates that have the potential to impact the entire US biosimilar industry.

October 31, 2023

A recent study found that a pegfilgrastim biosimilar was effective against chemotherapy-induced neutropenia and had comparable safety and efficacy profiles compared with the originator (Neulasta) in patients with breast cancer.

October 29, 2023

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, reflects on data concerning the potential for adalimumab biosimilars to gain significant market share.

October 28, 2023

A poster from AMCP Nexus quantifies trends in biosimilar coverage within Tufts Medical Center, finding that payer coverage of these products has increased but individual preferences among payers still vary.