Hungary’s two largest pharma firms, Egis Pharmaceuticals and Gedeon Richter, are stepping up their biosimilars offering; providing the European market with more affordable biologic medicines and bolstering Hungary’s footprint in biologics R&D.
Biosimilars in Europe
Over the past decade, over 80 biologic molecules have been launched worldwide. By 2020 the global market of biologic medicinal products is projected to exceed USD 390 billion and its value is estimated to account for up to 28 percent of the global pharmaceutical market.
Similarly, the first worldwide biosimilar medicine, somatropin, was approved in the EU in 2006. Since 2006, EU approved biosimilar medicines have generated more than 400 million patient days of clinical experience worldwide. Over 15 European countries have manufacturing sites for biosimilar medicines or biosimilar candidates under development and evaluation.
While first thoughts of key biosimilar markets are of course France, the UK, Germany, Switzerland, etc., the most advanced countries in Central and Eastern Europe (CEE) are also establishing a strong position in this emergent field. For example, Hungary’s two largest national players, Egis Pharmaceuticals and Gedeon Richter have both contributed to the growing sector in Europe.
Egis is an important player in the EU market for biosimilar medicines having launched its first biosimilar monoclonal antibody (mAb) product in 2013. The company has been a pioneer in providing cost-effective treatments for autoimmune patients through such products. Since then, Egis has developed two other biosimilars related to autoimmune diseases and oncology which are marketed in 15 countries in CEE and the Commonwealth of Independent States (CIS) region.
We are committed to providing our patients with access to leading-edge therapeutic solutions at affordable prices in CEE and the CIS countries
István Hodász, CEO, Egis
Most recently, the company signed an exclusive partnership in January 2019 with Mundipharma to distribute a pegfilgrastim biosimilar in the region. “Egis is now launching its fourth biosimilar drug. We are committed to providing our patients with access to leading-edge therapeutic solutions at affordable prices in CEE and the CIS countries,” emphasized István Hodász, the company’s CEO.
Under the terms of the agreement, the company acquired exclusive rights to market the drug that reduces the incidence of neutropenia, a common side effect of chemotherapy, in Hungary, Romania, Lithuania, and Latvia.
In addition, Hungary’s other leading domestic player, Gedeon Richter, has launched a teriparatide biosimilar for the treatment of osteoporosis in men and women who have a high risk of fracture. The European Commission granted a marketing authorization for the drug in January 2017 and Gideon began to introduce the biosimilar in Europe after the patent of the reference product expired in August 2019.
The launch of … Terrosa … reflects our commitment to the development of knowledge-intensive pharmaceuticals
Gábor Orbán, CEO, Gedeon Richer
“We welcome the launch of our first self-developed biosimilar product, Terrosa, in Europe, as it reflects our commitment to the development of knowledge-intensive pharmaceuticals, such as biopharmaceuticals,” proclaimed CEO Gábor Orbán.
Moreover, since 2018, in collaboration with Eötvös Loránd University, the Hungarian Academy of Sciences, and the University of Debrecen, Gedeon Richter has led a research program to develop biosimilars in the areas of oncology and immunology. The total budget of the project has reached more than HUF 6.64 billion (USD 22.4 million) and marks the first time that the development of a mAb-containing active ingredient and a pharmaceutical preparation has been carried out in Hungary.