Newsroom

Lotus Pharmaceuticals Obtained European Approval of Gefitinib, A Generic Iressa®, For Multiple European Countries as First Wave Generics

Posted on 5.9.2018

Lotus Pharmaceuticals announced that it has successfully concluded registration procedures for Gefitinib 250mg tablets in multiple European markets for its generic version of Astra Zeneca’s IRESSA®. IRESSA® is a drug indicated for first line non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK. There is one generic competitor along with its many licensees currently in the same region who received their procedure closure around the same time as first wave generics. 

Lotus Chairman Andrew Lin said that the Company filed Gefitinib through decentralized procedure (DCP) with Iceland being the reference member state (RMS) in June 2017. The end-of-procedure confirmation (EOP) came yesterday. Andrew believes that “we are well ahead of building a comprehensive portfolio of solid oral dosage oncology portfolio developed in house” while he indicated that the Company is preparing for a pan-Europe launch with Alvogen and other partners in 2019 in more than 20 countries.

European sales of Gefitinib in 2017 were $ 136 million based on IQVIA (formerly known as IMS) data. In addition to this clearance, Lotus is looking at a handful of approvals in APAC countries later this year for Gefitinib.