July 09, 2025
The US biosimilar market expands with new denosumab options, enhancing treatment for patients with osteoporosis and bone-related metastases.
July 08, 2025
July 07, 2025
July 05, 2025
July 04, 2025
November 11th 2023
By Skylar Jeremias
The use of biosimilars of tumor necrosis factor (TNF) inhibitors within Poland’s public payer saved over €243 million from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone.
November 10th 2023
By The Center for Biosimilars Staff
Here are the top 5 biosimilar articles for the week of November 6, 2023.
November 9th 2023
A real-world analysis from Japan confirmed that CT-P13, an intravenous infliximab biosimilar, had comparable safety and efficacy to the reference product (Remicade; infliximab) in patients with immune-mediated inflammatory diseases.
November 8th 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 7th 2023
Panelists discuss reference biologic and biosimilar concentrations as well as the importance of citrate-free, less frequent injectable medications.
Experts compare approaches to prescribing biosimilars over reference drugs.
A Chinese randomized study in healthy participants found comparable pharmacokinetic, pharmacodynamic, and safety profiles between LY01011, a denosumab biosimilar, and its originator (Xgeva).
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.
November 5th 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 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.