New Biosimilar Pharmaceutical Products

“New biosimilar pharmaceutical products”, KMOP-1.1.4-09-2010-0155
START DATE: 2011-01-03


Implementation of innovative activities that directly support market launch processes—enabling Egis Pharmaceuticals PLC to enter a new segment of the market for biological medicinal products.
Introduction of a number of monoclonal antibody (mAb) products—the category with the highest development and market potential within the biosimilar product range of biological medicinal products.
Besides our already established presence on the market of classic, small-molecule pharmaceutical products, to become a major player in the Central Eastern Europe biological products market over the next 10 years.



Within the framework of this project, we carried out the professional activities, industrial property rights tasks, and registration and business development activities that were required to obtain the licenses of the planned biosimilar products. One of the products in the portfolio has already been successfully registered in some former Commonwealth of Independent States countries and in the EU during the project implementation period.
As part of this project, we have created a laboratory suitable for the investigation of heat-sensitive biological substances, within which modern analytical equipment has been installed and seven new development analysts have been appointed—who have already performed analytical method transfer and development tasks for two products.
We have developed a new, complex logistics system for the packaging, labeling, transportation and storage of biosimilar products produced with special technology. The system ensures a cold chain between 2-8 °C across the whole process.
Having completed the development processes, Egis Pharmaceuticals PLC has been successfully prepared for the market launch of new biosimilar products since 2013.


Information on the proposed project:

Principal of the tender: National Development Agency
Title and code of the call for tender proposals: “Support of corporate innovation”, KMOP-2009-1.1.4
Title and ID of proposed project: “New biosimilar pharmaceutical products”, KMOP-1.1.4-09-2010-0155
Submission date of proposal: 31/05/2010
Date of decision about funding: 19/07/2011
Granted amount: HUF 97,542,953
Time period for project implementation: 03/01/2011 - 28/02/2013
Total costs of the project: HUF 390,171,814
Provided funding: HUF 89,070,175

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