Correspondence: Robert I. Roth, The Weinberg Group Inc., One Market, Steuart Tower, Suite 1450, San Francisco, California 94105, USA. E-mail: bob.roth@weinberggroup.com

¹has obtained MD, and PhD, and is Medical Director at The Weinberg Group Inc. Before joining The Weinberg Group Inc., Dr Roth was Director of Medical Research at LifeScience Economics, and was a faculty member in the Department of Laboratory Medicine at the University of California, San Francisco. Dr Roth provides consultation in all phases of the research, development and marketing of FDA-regulated drugs, biologics and medical devices.

²has obtained RPh and PhD, and is the Vice President of Clinical Pharmacology & Biopharmaceutics at The Weinberg Group. Before joining The Weinberg Group, Dr Fleischer held several scientific review and managerial positions at the United States Food and Drug Administration. Since joining The Weinberg Group, Dr Fleischer has been actively involved in managing programmes specifically geared toward the problem solving of pharmaceutical issues for large and small drug firms, always with an eye toward enhancing the client's position.

Received 28 January 2009; Revised 28 January 2009.

Abstract

Recent years have seen the approvals, more so in the EU than the United States, of follow-on biological drugs. These products have been new formulations of recombinant therapeutic proteins, developed to compete with the marketed originator products. Intended to closely mimic the originator products in terms of chemistry and therapeutic properties, these so-called 'biosimilar' products were initially conceived to be developed according to abbreviated development programmes, presumably at a substantial cost savings to both the drug developer and the consumer. With several such products now recently approved, however, it has become clear that their development programmes have been quite extensive and not particularly abbreviated. Accordingly, cost savings to consumers appear to be relatively modest.