Adalvo announces ready-to-file dossier completion on Pomalidomide hard capsules development

23 March 2021

Adalvo is delighted to announce the completion of an eCTD format dossier on our Pomalidomide hard capsules development. We progress forward to close our pending partnering contracts and move into filing as soon as regulatory exclusivity protection expires. We also believe we can be among the first companies going for an approval in EU.

To remind Adalvo did successfully close our Pivotal BE clinical trials in November 2020. The Pomalidomide Pivotal BE study was carried out on Pomalidomide Hard Capsules 4mg (Adalvo) and Imnovid® Hard Capsules 4mg (Celgene). It´s important to note that even if Adalvo conducted the biostudy on highest strength, we can offer the full line of strengths of Pomalidomide across all regions.

Adalvo will be submitting a generic and bioequivalent version of Imnovid® hard capsules that has been fully developed in-house. Imnovid® is a leading oncology drug originally developed by Celgene that is indicated for the treatment of multiple myeloma. Branded product currently sells around $1.9 billion globally based on IQVIA market intelligence report.

The Adalvo product was developed by Lotus pharmaceuticals, an Alvogen affiliate and is part of a comprehensive portfolio of solid oral dosage oncology drugs being developed by our company.

Disclaimer: Pomalidomide which is subject to patent protection is currently not offered or made available in countries where patents are in force.