Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen’s biosimilar was approved under the brand name Mvasi (bevacizumab-awwb).
FDA’s approval of Mvasi follows an advisory committee’s unanimous backing of the treatment and is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates
Mvasi is biosimilar to Avastin, though not an interchangeable product. FDA has now approved seven biosimilars.
Mvasi has been approved 13 years after the blockbuster Avastin first won FDA approval, though it's unclear how soon Mvasi will be marketed in the US as patents could protect Avastin until 2019. Last March, Roche's complaint against Amgen in regards to the biosimilar was dismissed. Amgen said it would not comment on the launch date or price of Mvasi.
Last December, Amgen and partner Allergan also submitted what they said is the first Avastin biosimilar application with the European Medicines Agency (EMA). And in India, generics company Hetero launched its Avastin biosimilar in June 2016, known there as Cizumab. Last month, FDA sent a warning letter to one of Hetero's manufacturing sites.
The approval in the US is for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. Specifically, the approved indications include:
Tags: Amgen, Mvasi, Avastin biosimilar