June 16th 2024
By Skylar Jeremias
In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
June 6th 2024
American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.
June 5th 2024
Posters from the American Society of Clinical Oncology (ASCO) 2024 annual meeting demonstrate positive safety and efficacy data for denosumab and pegfilgrastim biosimilars.
March 5th 2024
Sandoz’ Wyost/Jubbonti (denosumab-bddz) references Prolia and Xgeva and can be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.
January 30th 2024
Coherus Biosciences has sold its ranibizumab biosimilar (Cimerli) to Sandoz; Celltrion has completed its biologics license application filing for its tocilizumab biosimilar (CT-P47); Alvotech shares positive pharmacokinetic results for its denosumab biosimilar candidate.
January 11th 2024
As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.
November 25th 2023
By Deana Ferreri, PhD
A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.
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
A Chinese randomized study in healthy participants found comparable pharmacokinetic, pharmacodynamic, and safety profiles between LY01011, a denosumab biosimilar, and its originator (Xgeva).
August 24th 2023
By Justina Petrullo
Biosimilar teriparatide improves bone mineral density (BMD) when patients with osteoporosis are treated for a year or more.
