Adalvo is pleased to announce that the successful Pivotal BE Study for Afatinib Film-Coated Tablets has been completed and we are now preparing our dossier submission which is scheduled for November 2023.
Our product is Afatinib 20mg, 30mg, 40mg & 50mg FCT and has been developed based on the reference brand Giotrif® (Boehringer Ingelheim). This product is fully developed by our sister company, forming part of the Aztiq group.
Afatinib is used in the treatment of non-small cell lung cancer and has been selling for $306 Mn across the globe in 2022, according to IQVIA.
Based on our positive results, we believe we will be in a first-to-file first-to-market position in all our major markets.
Partner up now!
At Adalvo, there are no half measures – we arealways on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward.
ajish.rajan@adalvo.com – Central & Eastern Europe, Russia & CIS
jose.rendueles@adalvo.com- North Europe, APAC, MENA & Israel
margarida.neves@adalvo.com – Brazil
marta.puig@adalvo.com- LATAM (exc. Brazil) & South Europe
paulo.rodriguez@adalvo.com – Europe
supreet.sharma@adalvo.com – UK/Ireland, North America & South Africa
arni.baldursson@adalvo.com - Head of Global BD&L
Disclaimer: Products which are subject to patent protection are currently not offered or made available in countries where patents are in force.