ELIZABETH N. SPAR¹, TOM WINTNER²
1. Sunstein Kann Murphy & Timbers LLP, 125 Summer Street, Boston, MA 02110-1618, USA
2. Edwards Wildman Palmer LLP, 111 Huntington Avenue, Boston, MA 02199, USA

Abstract

Producers of biosimilars must prepare a global strategy for development of a biosimilar product to ensure maximum benefit from their investment. This article discusses numerous factors that will affect cost and time associated with biosimilar development.

The global market for biologics is currently estimated at greater than $100 billion, and it is estimated that by 2015 the global market for biosimilars will increase from $200 million to more than one billion with the expiration of patents for critical blockbuster biologics. This huge market opportunity has spurred the issuance and implementation of guidelines for biosimilar approval across the world. Thus, to ensure maximum benefit from the investment in biosimilars, producers will need to develop a global strategy for manufacturing, clinical development, regulatory approval, marketing and sales. The choice of where to develop a biosimilar will require careful consideration of a number of factors that will affect cost and time associated with development.

REGULATORY GUIDELINES
The first key issue is whether regulatory guidelines are in place for biosimilars in the country/region to be entered, and, if such guidelines exist, how stringent they are. Guidelines for biosimilars are in place in most regions with advanced economies (such as the European Union, Canada and Japan), but some developed countries still lag behind in finalizing guidelines (t ...