© 2021 MJH Life Sciences and Center for Biosimilars®. All rights reserved.
© 2021 MJH Life Sciences™ and Center for Biosimilars®. All rights reserved.
September 25, 2021
Biosimilar User Fee Act reviews have been slowed by the pandemic and the FDA has opened a public comment period as it plots the course through 2027.
September 24, 2021
September 23, 2021
September 22, 2021
September 22nd 2021
The HHS plan ordered up by President Biden for combatting high drug prices is a hodgepodge of ideas that have long circulated in Washington, DC, but can any of them be made to stick? An intellectual property and FDA policy expert, Chad Landmon, JD, shares his perspective.
September 21st 2021
By Tony Hagen
Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.
September 20th 2021
Byooviz (ranibizumab) was approved for multiple ophthalmologic conditions, although market launch is at least 9 months away, owing to patent protections on the originator product.
Investigators said TX05 met pathologic complete response criteria for equivalence to the originator product, Herceptin. The biosimilar candidate also fell within objective response rate, immunogenicity, safety, and tolerability margins for similarity.
September 19th 2021
Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.
September 18th 2021
By Deana Ferreri, PhD
According to a multiyear, retrospective study, filgrastim biosimilar Zarxio cost $20.50 more on average per administration than reference Neupogen in the hospital outpatient setting.
September 17th 2021
Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.
BCD-021 demonstrated equivalence in a phase 3 study involving Russian and Indian patients with advanced non–small cell lung cancer (NSCLC).
Here are the top 5 biosimilar articles for the week of September 13, 2021.
September 16th 2021
MIL60 bevacizumab biosimilar candidate demonstrates equivalence to the originator Avastin in a population of Chinese patients with non–small cell lung cancer (NSCLC) treated in a frontline setting.