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Adalvo announces successful dossier submission for Apremilast film-coated tablets

18 January 2023

Adalvo is pleased to announce the successful EU dossier submission for Apremilast Film-Coated tablets on day-1, after expiry of data exclusivity. This product has been developed in collaboration with one of our strategic partners.

Our product has been developed based on the reference brand Otezla Film-Coated Tablets, which is indicated in the treatment of Psoriatic Arthritis, Psoriasis and Behçet’s disease. The brand sold approximately $3.5bn globally in 2021, having a significant growth potential with Global 3Y CAGR at 15%, according to IQVIA.

Martina Feitzinger, Senior Vice President, Strategic Scientific Affairs, comments, “We are thrilled to be filing on expiry of data exclusivity, to ensure a successful day-1 launch. Apremilast offers an easy-to administer oral treatment for Psoriasis, exemplifying Adalvo’s ability to bring high quality medications to patients across the globe”.

Adalvo offers a range of products, as depicted below, and we will continue to extend our offerings within this segment.