Gedeon Richter Areas of Expertise Biotechnology
Biotechnology
Contract development and manufacturing
Richter identified a number of years ago, the potential growing importance of biological drugs over the medium to long-term and in 2006 took the strategic decision to enter this novel, high added intellectual value field. In doing so Richter’s management was confident that its decades long expertise in fermentation, a most sensitive procedure used both in the manufacturing process of biological drugs and in that of steroids, would create a competitive edge over many of its peers.

Initially, Richter acquired in 2007 a family owned R&D and manufacturing site headquartered in Hamburg, Germany, establishing with Helm AG a joint venture business with Richter as the majority shareholder. Richter Helm Biologics comprises a plant able to perform the manufacturing of bacterial and yeast cell based proteins, a pilot plant and a linked analytical and R&D laboratory unit.

A much larger scale investment followed with the construction in Budapest of a pilot plant and a laboratory to enable the development of biologics based on mammalian cell expression. This was complemented with a totally new manufacturing unit built in the industrial park of Debrecen in Eastern Hungary. These assets enable development in Budapest and manufacture in Debrecen of biological drugs based on mammalian cells fermentation.

When selecting candidate products Richter proceeded very carefully, focusing on certain therapeutic areas, notably Rheumatology/Osteoporosis and Oncology. These areas are considered to be among the highest growth rate therapeutic segments.

As is customary when it comes to relatively higher risk or significantly larger investments, Richter identified strategic alliances with companies similarly interested in biosimilars in order to share both risks and costs. In this endeavour Richter has concluded such agreements, one with Mochida for the Japanese market, one with STADA based in Germany. Further partners are sought with the aim of establishing joint product development activities.

What is a biosimilar?
A biosimilar medicine is a biological medicine that is developed to be highly similar to an already authorised biological medicine (the ‘reference medicine’).
 The biosimilar medicines do not have any significant differences from the reference medicine in terms of quality, safety or efficacy. By competing with original biologics across a growing range of therapy areas, biosimilars enable stakeholders – including payers, physicians and patients – to benefit from greater choice when it comes to treatment options. A large and diverse group of around 180 manufacturers globally are investing in the development and commercialisation of biosimilars, bringing with this investment the promise of high-quality biologic therapies at a lower cost.