By Barbara Obstoj-Cardwell. Editor
In the news last week was new guidance from the US Food and Drug Administration on the interchangeability of biosimilars, but there are still challenges ahead. ImmunoGen had a major setback with the FDA calling for a further study on its cancer drug mirvetuximab. Boehringer Ingelheim’s patent settlement with AbbVie over Cyltezo, its copy version of Humira, marks the eighth such deal as to when biosimilars of the world’s biggest selling inflammatory diseases drug can come to the US market. Research news was a ‘tale of two stories', with Agios Pharmaceuticals presenting positive new data on Tibsovo in cholangio carcinoma, while AbbVie’s Depatux-M failed to meet the primary endpoint of a Phase III glioblastoma study.
Road ahead still difficult for biosimilars in the USA despite new FDA guidance on interchageability
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze