Correspondence: Suzanne M. Sensabaugh, MDS Pharma Services, 2200 Renaissance Blvd., Suite 400, King of Prussia, PA 19406-2755, USA. Tel: +1 800 358 0700 Ext 516; Fax: +1 484 322 1481; E-mail: Suzanne.Sensabaugh@mdsinc.com

¹is VP, Biopharmaceutical Development, MDS Pharma Services, where she is responsible for managing and directing the consulting group in Development & Regulatory Services and providing professional guidance to clients. Prior to this position, she was VP, Regulatory Affairs, and Senior Director for Global Biogenerics, Teva Pharmaceutical Industries Ltd, where she developed regulatory strategy and submissions for biotechnology products. She has more than ten years of experience at the FDA/CBER as a researcher, product reviewer, and inspector for biologics. She also was involved in the development and implementation of SOPs, Guidance, regulations, and laws. Prior to leaving the Agency, she was Special Assistant to the Associate Director of Policy, Office of the Center Director. She has experience in the industry as Associate Director, Regulatory Affairs, at Genzyme Corporation where she directed, planned, and implemented global regulatory activities, and as VP, RA & Quality, SICOR Inc, Biotechnology Division, where she was responsible for global regulatory affairs, quality assurance, and control. She is the industry representative to numerous scientific committees and the ICH. She received her MBA from Duke University, MS in Biotechnology from Johns Hopkins University, and BS in Zoology from the University of Maryland.

Received 11 January 2007; Revised 11 January 2007; Published online 20 February 2007.

Abstract

Biological generics are protein products comparable in quality, safety, and efficacy to the brand product and marketed after exclusivity has expired. In the US, sales of biologics are expected to exceed US$60bn by 2010 while in the EU the market size for 'biosimilars' is estimated to be US$16–20bn per year by 2010–2011. Biological drugs for which the patent period has expired or is soon to expire include insulin, human growth hormone, interferons, erythropoetin, growth factors, monoclonal antibodies, and blood factors. Not all biological products are currently candidates for various technical and scientific reasons; however, most are. The economics of biological generics will be different than chemical generics. While savings equivalent to a chemical generic may not be realised by the end user, savings in terms of absolute dollars will be substantial. In the EU, so far two 'biosimilars' have been approved, while in the US the FDA is reviewing and approving Follow-on Protein Products under the FD&C Act, §505(b)(2). As with chemical generics, challenges and opportunities exist. The entry of biological generics will result in rewards for all. As these products range in the complexity of their molecular structure and indications, the mantra of biologics — case-by-case drug development — will need to be followed.