Biosimilar Development: the Race to Market Continues..

2012 will certainly be memorable as an Olympic year, but it has also seen a flurry of activity in the race to market biosimilar products. Keen to participate in this event, many countries throughout the world have established legal and regulatory pathways which allow manufacture of “copies” of a patent-expired biotherapeutic product. However, these are not simple generics as in the case of small molecules. The fundamental difference with these large, complex protein molecules is that they cannot be absolutely identical to the original. Instead companies developing these “copies” must demonstrate that they are similar by performing a side-by-side comparison with a reference sample of the originator molecule. Consequently, there are many challenges – legal, regulatory, non-clinical and clinical – which manufacturers must rise above to develop biosimilar products for global markets. This article introduces the concept of biosimilars, their importance in the global marketplace together with some historical background, and an update on the current regulatory situation. It will also address the issues involved in demonstrating physicochemical similarity of the biosimilar molecule to the originator – one of the first hurdles to be negotiated prior to biological and clinical testing. AUTHOR: FIONA M GREER BSC (HONS) MSC PHD , GLOBAL DIRECTOR, BIOPHARMA SERVICES DEVELOPMENT, SGS M-SCAN