Center for Biosimilars®
By Skylar Jeremias. October 17th 2024. Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their …
Immunology - Center for Biosimilars
Skylar Jeremias. July 23rd 2024. About half of the patients in a European study who transitioned from reference adalimumab to a biosimilar version stayed on the biosimilar at the 1-year mark. However, researchers warned about a possible nocebo effect resulting in some patients switching back to the originator.
News - Center for Biosimilars
Nov 4, 2024 · Celltrion Sets Sights on 2030 With Expanded Biosimilar Portfolio, Market Reach. Skylar Jeremias. November 6th 2024. Celltrion plans to commercialize 22 biosimilars by 2030, expanding its global presence with robust sales growth driven by core biosimilars and new launches like subcutaneous infliximab.
Biosimilar Approvals - Center for Biosimilars
Nov 1, 2024 · This page was last updated November 01, 2024. About. Editorial
Rare Disease - Center for Biosimilars
Oct 17, 2019 · May 29th 2024. The FDA approved Bkemv (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability. IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe. By Skylar Jeremias. January 10th 2024. Samsung Bioepis' Eculizumab Biosimilar Approved in Europe.
Oncology | Clinical News & Insights - Center for Biosimilars
October 11th 2024. Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira. Duke Publishes Recommendations for Developing CGT Biosimilars. By Skylar Jeremias.
BioRationality: FDA Simplifies Glycan Profiling of mAbs, a …
Jul 29, 2024 · The most critical test of biosimilarity for recombinant therapeutic proteins derived mainly from Chinese hamster ovary cells, but others as well, is the comparison of post-translational modifications, of which the glycosylation is the most critical but also most variable and complex to test, adding substantial cost of batch release, and thus the cost of goods sold, as well as establishing ...
Future Biosimilar Trends, Challenges, and Opportunities
Sep 29, 2024 · 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. Dr Chelsee Jensen Speaks on How Health Systems Can Build Confidence in Biosimilars.
Centus Bevacizumab Candidate Demonstrates Equivalence in …
Aug 19, 2021 · Serious TEAEs were experienced by 25.1% of patients in the FKB238 arm and 26.0% of patients in the RP cohort. Patients with non-sq-NSCLC typically present with inoperable, locally advanced, or metastatic disease, which is incurable, although with the introduction of kinase inhibitors and immune checkpoint inhibitors, 5-year survival has improved to about 25%.
Duke Publishes Recommendations for Developing CGT Biosimilars
Oct 9, 2024 · In light of high costs for current cell and gene therapies (CGTs) and promise of biosimilars to lower costs on biologic drugs, the Duke Margolis Institute for Health Policy published policy recommendations for developing a robust competitive market for biosimilar CGTs. 1. The FDA has approved numerous innovative cell and gene therapies ...