In further reinforcement of its generic API portfolio — which is already among the largest and most diversified in the world — Olon announces that it has completed all process and analytical validations for Trilaciclib. This new molecule is added to Olon’s record of 200 generic APIs and over 450 Drug Master Files.

Thanks to a consolidated R&D strategy supporting medical and scientific advances in targeted drugs and significant investments in research, the group’s API portfolio has grown significantly over the years, with considerable diversification in the areas of oncology. Trilaclilib — the first injectable adjuvant for cancer therapy to become part of Olon’s portfolio — was developed in amorphous form using a proprietary process.

“We pursue diversification from different perspectives: classes of molecules, volumes, therapeutic areas. In this case, we diversified the technology and pharmaceutical form to offer an alternative to oral solids for this specific adjuvant therapy,” said Luisa Volpati, BU Director, Generics. “We started with solid in-house expertise and knowledge; in fact, we have quite a large list of injectables, many of which are for cancer treatment, such as rubicins, bendamustine, melphalan and clofarabine.”

Trilaciclib is an intravenous cell-cycle inhibitor that transiently maintains immune cells and haemopoietic stem and progenitor cells in G1 arrest. By protecting the immune cells and bone marrow from chemotherapy-induced damage, trilaciclib has the potential to optimise antitumour activity while minimising myelotoxicity.