In 2015 the members of the program group have collaborated in filing of the dossier for biosimilar pegfilgrastim to the Food and Drug Administration (FDA) and European Medicines Agency. FDA and EMA accepted the dossier and the dossier review is currently ongoing. GMP production of the pegfilgrastim biosimilar is located in Biopharmaceuticls Mengeš. In 2015 the members of the program group have also collaborated in filing of the dossier for biosimilar etanercept to the Food and Drug Administration (FDA) and European Medicines Agency. As in case of pegfilgrasim, FDA and EMA accepted the dossier and the dossier review is currently ongoing.
This patent describes a novel process for producing an active pharmaceutical ingredient (API) preparation in the form beads. The main advantage of the novel method is the ability to directly manufacture an aqueous suspension of API in the form of undissolved particles in a single processing step. Furthermore, very high drug loadings (approaching 100%) can be achieved using this approach.
F.32 International patentCOBISS.SI-ID: 1580380
The present invention relates to erythropoietin (EPO) conjugates having a high bioavailability and efficacy, especially when administered perorally. Also provided are methods for preparing the EPO conjugates, their use for treating various diseases, and pharmaceutical compositions comprising said EPO conjugates, alone or in combination with absorption enhancers and/or coating polymers.
F.32 International patentCOBISS.SI-ID: 31900121
The present invention relates to compositions comprising erythropoietin and one or more adsorption enhancers and/or one or more bioadhesive polymers for oral administration. The adsorption enhancers are selected from the groups of “CYMAls” and “PMALs”. The present invention relates also relates to corresponding nanoparticle formulations for oral administration. The compositions and formulations of the invention enhance the oral bioavailability of the drug.
F.32 International patentCOBISS.SI-ID: 5693978