Delivering quality therapy since 1901

Innovation and high added value: Biosimilar product development

​Biopharmaceuticals (often referred to as 'biologics') have taken a significant share of the global pharmaceutical market in the last two decades. Within the European Union, every third new drug authorisation is of biotechnological origin. In 2015, globally, seven of the top ten selling drugs were biopharmaceuticals. Biologics account for just under 50 percent of all products at clinical phases within development pipelines of pharmaceutical companies globally.

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 Oncology and Immunology. 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.

 

Biosimilars

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

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 Elli Lilly's FORSTEO. According to the relevant license agreements, it is expected to be launched under both Richter and STADA labels in geographical Europe following the patent expiry of the original product.

 

Pegfilgrastim

Pegfilgrastim, a pegylated recombinant, human granulocyte-colony stimulating factor is used in cancer patients to help with some of the side effects of their treatment. Chemotherapy that is cytotoxic also kills white blood cells, which can lead to neutropenia and the development of infections. Pegfilgrastim is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia.

In December 2016 Richter announced that it has withdrawn its Marketing Authorization Application (MAA) from the EMA for its biosimilar pegfilgrastim. The MAA filing was based on comparative quality, non-clinical and clinical data from the Company's completed biosimilar development programme. During the November 2016 CHMP meeting, the CHMP indicated that the data provided did not allow the Committee to conclude a positive benefit risk assessment. The Company's management is committed to continue the clinical development and regulatory process of its biosimilar pegfilgrastim in order to eliminate the remaining uncertainties identified during the review process by the CHMP.

Richter is also working on a portfolio of biosimilar monoclonal antibodies, which vary between clinical and late to early stage preclinical stages of development. This portfolio includes a trastuzumab biosimilar, which as part of a technology transfer and license-in agreement in respect of its development and commercialization signed in October 2016 with DM Bio, a Korean developer, will be further developed and commercialised in certain territories.

This portfolio of mammalian cell fermentation products will fill capacity at the Company's Debrecen facilities. These facilities are undergoing capacity extension in order to cope with future demand and in order to provide further state-of-the-art biotechnology manufacturing capabilities.