Bogsch, Erik Jr.

Dr. Erik Bogsch
Head of the Biotechnology R&D Division at Gedeon Richter Plc.

Dr. Erik Bogsch is Head of the Biotechnology R&D Division at Gedeon Richter Plc. He is responsible for leading the R&D effort in the development of GR’s biotechnology pipeline.
Gedeon Richter Plc. is engaged in the development and manufacture of both bacterial cell fermentation based and mammalian cell fermentation based biosimilar products. GR has R&D, analytical & manufacturing capabilities in multiple locations in Hungary & Germany.
Dr. Bogsch, has a Natural Sciences degree from the University of Cambridge and a PhD in cell biology from the University of Warwick. Following a brief postdoctoral academic research career, he worked in the food industry for many years in R&D, Quality & Manufacturing roles in the UK, Hungary & Germany. He joined Gedeon Richter Plc. in 2012, as commissioning lead for GR’s biotechnology factory in Debrecen, Hungary, before moving into his current role in 2014.

Biosimilars Landscape – Development, Regulatory & Market Access Challenges

The past decades have seen the breakthrough of biologics within the pharmaceutical sector. As many of these blockbuster biological products’ patents expire, there is an enormous opportunity for biosimilar products to make these, often life-saving, medicines accessible to considerably more patients, particularly in the fields of oncology and immunology.

The objective of the presentation is to give an overview of biosimilar products, their development challenges, the regulatory requirements they must adhere to and a view of their market potential.

Development and manufacture of biologics is very different to traditional small molecule pharmaceuticals. Stable expression of large protein molecules and their purification are the key challenges for drug substance development and manufacture. Most biologics are parenteral products requiring appropriate final formulation development and specific fill & finish manufacturing technologies.

The precise characterisation of biologics poses an exciting challenge for analytical teams the world over, and is of pivotal importance in the development of biosimilars. In fact, the very stringent regulatory requirements applied to biosimilar developments are in part due to the difficulty posed in precise characterisation of such macromolecule based medicines. Significant clinical development programmes are expected of biosimilars, very differently to small molecule generic developments.

Further to development and regulatory challenges, market access requirements also differ and present new challenges as well as opportunities for companies with biopharmaceutical portfolios.

Development, manufacture and commercialisation of biologics, including biosimilars, have a higher entry barrier than small molecule developments due to differentiated know how requirements, high capital investment, development and manufacturing costs in addition to changing regulatory and commercial landscapes.