In 2016 Sandoz (LEK is a part of) received marketing approval for biosimilar etanercept from US Food and Drug Administration (FDA). The FDA approval followed a unanimous vote (20-0) by the FDA's Arthritis Advisory Committee (AAC) to recommend use in all indications of the reference product (rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA)). Recommendation of the committee followed the presentation of complete package from the global development program, which confirmed the biosimilarity of Sandoz biosimilar etanercept to reference product. Besides the researchers from the LEK program group, numerous researchers from Sandoz contributed to the project, which shows very high complexity of development, manufacturing, registration and marketing of biosimilars.
F.06 Development of a new product
Program New generation of biological medicines (proBioPharm.SI) was approved in 2016. Value of the program is 8,81 mEUR, MESS finances up to 5,97 mEUR (up to 68%). Public call is partially financed by EU (European fund for regional development). The consortium is formed by 10 partners: Centre of Excellence for Biosensors, Instrumentation and Process Control (CO BIK), Lek d.d., Instrumentation Technologies d.d., Metronik d.o.o., BIA d.o.o., National Institute of Biology, Faculty of Computer and Information Science, Faculty of Electrical Engineering, National Institute of Chemistry, Faculty of Chemistry and Chemical Technology. Activites started in october 2016 and program will last till june 2020. Program is organized into seven complementary research – development projects (RPP). Lek is collaborating on all seven projects (RPP), researchers from Lek lead two of them: dr. Drago Kuzman leads RPP2 and dr. Aleš Belič leads RPP5. The goal of Biopharm.SI program is to focus on development and manufacturing of biological medicines at basic science level, to understand biolgical processes, identify critical process parameters, development of sensors and monitoring of parameters, development of software tools for analysis of data and usage of the analysis results in process control and results prediction. Program BioPharm.SI represents great collaboration of the industry, academia and small innovative companies which creates huge synergistic effect. Program BioPharm.SI is important because it enables creation of excellent knowledge in Slovenia, it enables researchers to position themself in demanding global environment and at the same time promotes generation of new, technologically demanding workplaces in Slovenia, which is of key interest for the country. Following members of program group are collaborating on BioPharm.SI: dr. Drago Kuzman, dr. Aleš Belič, dr. Matej Horvat, dr. Boštjan Japelj, dr. Barbara Podobnik, dr. Tine Porenta, dr. Mitja Mitrovič, and dr. Dejan Arzenšek.
F.09 Development of a new technological process or technology
The members of the program group have collaborated in filing of the dossier for biosimilar pegfilgrastim to the European Medicines Agency (EMa). EMA accepted the dossier and review is currently ongoing. GMP production of pegfilgrastim biosimilar is located in Biopharmaceuticals Mengeš. This achievement represents great example of the transfer of research and development achievements into complex industrial production with high added value in the Republic of Slovenia
F.06 Development of a new product
The patent describes a new approach for the preparation of chiral halogenoalkanes by asymmetric hydrogenation of halogenoalkenes. Obtained halogenoalkanes are useful as intermediates in the synthesis of pharmaceutical active compounds. For example, alfa-halogeno boronic esters can be used for preparation of boronic acid and ester compounds, such as bortezomib.
F.32 International patentCOBISS.SI-ID: 1564764
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