Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate

November 8th 2023

By Skylar Jeremias

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.

Biosimilar Administration Considerations Impacting Patient Experience

November 7th 2023

Panelists discuss reference biologic and biosimilar concentrations as well as the importance of citrate-free, less frequent injectable medications.

Decision-Making Process Surrounding Biosimilar Implementation

November 7th 2023

Experts compare approaches to prescribing biosimilars over reference drugs.

Denosumab Biosimilar Demonstrates Positive Safety Results in Chinese Study

November 7th 2023

By Skylar Jeremias

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

BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars

November 6th 2023

By Sarfaraz K. Niazi, PhD

The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.

Biosimilar Business Roundup for October 2023—Podcast Edition

November 5th 2023

By Skylar Jeremias

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.

Similar Safety Profiles of Biosimilar, Reference Pegfilgrastim Found in Clinical Studies

November 4th 2023

By Deana Ferreri, PhD

Researchers of a literature review found similar safety profiles between a biosimilar pegfilgrastim and its reference product (Neulasta) across several phase 1 and phase 3 clinical trials.

The Top 5 Biosimilar Articles for the Week of October 30

November 3rd 2023

By Skylar Jeremias

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

Physicians Agree on Safety of Biosimilars, Nonmedical Switching in IBD, Survey Says

November 2nd 2023

By Skylar Jeremias

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.

FDA Approves First Stelara Biosimilar, Wezlana

November 1st 2023

By Skylar Jeremias

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.