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 based in Hamburg, Germany, establishing with Helm AG a joint venture business with Richter as the majority shareholder. The site 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 complement a totally new manufacturing unit built in the industrial park of Debrecen in Eastern Hungary. This facility enables development in Budapest and manufacture in Debrecen of biological drugs based on mammalian cells.
When selecting candidate products Richter proceeded very carefully, focusing on two main therapeutic areas, notably osteoporosis and rheumatology. Both these areas are considered to be among the highest growth rate therapeutic segments.
With the establishment in July 2016 of a Biotechnology Business Unit, Richter has undergone a major restructuring of resources engaged in the development or biosimilars. These steps were taken to support all the efforts related to our biosimilar programme. The business unit includes near 200 employees and currently covers R&D, Clinical, Regulatory, Business Development, Project Management, Manufacturing and Marketing activities for the products under development in the biosimilar portfolio.
A biosimilar medicine is a biological medicine that is developed to be highly similar to an already authorized 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.
Teriparatide is identical to the biologically active fragment of the human parathyroid hormone, it replaces the natural hormone and stimulates bone formation. Teriparatide is used for the treatment of osteoporosis as it reduces the risk of bone fracture in various patient groups.
In early January 2017 the European Commission (EC) granted marketing authorization for Richter's biosimilar teriparatide, TERROSA. The biosimilar teriparatide has been developed by Richter-Helm BioTec GmbH & Co. KG. The product demonstrates biosimilarity to Eli Lilly's FORSTEO. Following the patent expiry of the original product the product has been launched in Europe in August 2019.